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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

Pills and Payments: India’s Unethical Drug Marketing Problem

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The recent exposé by The Economic Times, titled “Rx Name Unethical practitioners,” published on June 19, 2025, which brought to light allegations of a prominent global pharmaceutical company sponsoring extravagant foreign trips for doctors in violation of ethical codes, serves as an urgent reminder, yet again, of the persistent and deeply entrenched malpractices plaguing India’s pharmaceutical marketing landscape. While India proudly holds the title of “pharmacy of the world,” this distinction is increasingly overshadowed by unethical practices that jeopardize public health, distort prescribing patterns, and erode trust in the medical profession.

The Anatomy of Malpractice: A Systemic Issue:

The incident, highlighting the Department of Pharmaceuticals (DoP) apparently shielding names despite clear breaches, underscores a systemic failure in accountability. Unethical marketing manifests in various forms:

  • “Freebies” and Inducements: Offering gifts, money, travel, and hospitality directly influences prescribing behavior. This leads to unnecessary prescriptions, a preference for expensive branded drugs, and the over-medicalization of minor ailments.
  • Misleading Claims: Companies make unsubstantiated or false claims, misleading both professionals and the public, often with dangerous health impacts as highlighted by the Supreme Court.
  • Undue Influence in CME: Company-sponsored educational events often serve as thinly veiled marketing opportunities, subtly promoting specific products.
  • Lack of Transparency: The refusal to disclose names of doctors involved in unethical practices exemplifies pervasive opacity, shielding wrongdoers.

Why Self-Governance (UCPMP) Is Not Working and Malpractices Persist:

Despite the notification of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) 2024, malpractices continue to thrive. This is primarily because the UCPMP, even in its revised form, relies heavily on self-governance, which has proven ineffective.

Why Self-Governance Fails:

  1. Not a Full Law: While the UCPMP 2024 has moved from “voluntary” to “quasi-statutory,” it still isn’t a strong, legally binding law passed by Parliament. This means there are no direct legal punishments for violations. The DoP can only “recommend” action to other bodies or associations, lacking the power to impose immediate, significant fines or sanctions. Companies know this, which reduces their incentive to fully comply.
  2. Weak Punishments and Enforcement: The penalties under the UCPMP are often too light to deter large pharmaceutical companies, for whom the profits from unethical practices far outweigh a mere reprimand or expulsion from an industry association. Enforcement relies heavily on industry associations themselves (through Ethics Committees for Pharmaceutical Marketing Practices – ECPMPs). This creates a conflict of interest, as these associations are made up of the very companies they are supposed to regulate. There’s a natural tendency for these committees to be lenient or prioritize industry interests over stricter compliance.
  3. Lack of Proactive Investigation: Enforcement largely depends on complaints being filed. This means many unethical practices go unreported or unaddressed, especially when there’s an imbalance of power, making whistleblowing risky. The system isn’t designed for active investigation, but rather reactive response.
  4. Deep-Rooted Culture of Incentives: The Indian pharmaceutical market is highly competitive. Companies face immense pressure to push their products. The ingrained culture of offering incentives, even subtle ones, has become a “cost of doing business.” When competition is fierce, relying on competitors to self-regulate fairly is often wishful thinking.
  5. Loopholes and Vague Rules: Despite revisions, the code may still have gaps, or new, indirect ways companies promote drugs might not be clearly covered. For instance, the lack of mandatory public disclosure for payments made to doctors for research or advisory roles is a significant loophole that allows conflicts of interest to remain hidden.

In essence, self-governance simply isn’t strong enough to counter the massive financial incentives driving unethical marketing. It relies on goodwill and internal discipline in an industry where competitive pressures are intense, leading to a situation where the rules exist, but the teeth to enforce them are missing.

The Ripple Effect: Impact on Public Health and Trust:

These malpractices inflict significant harm: patients receive inappropriate or excessive treatments, leading to higher healthcare costs. Public trust in doctors and drug companies erodes, and market competition is distorted.

Moving Ahead: A Stronger Path to Ethical Marketing for Viksit Bharat:

Ensuring ethical pharmaceutical marketing practices is not just a matter of professional integrity; it is a fundamental pillar for achieving India’s cherished vision of Viksit Bharat by 2047. A developed nation thrives on a healthy, productive populace and a healthcare system rooted in trust and equity, free from commercial exploitation. The UCPMP 2024 is a vital starting point, but its success – and indeed, its contribution to this national ambition – hinges on taking critical next steps:

  1. Make UCPMP a Full Law: The code must become legally binding with clear, stringent punishments directly under a parliamentary act. This means no more personal benefits for healthcare professionals, strictly enforced by law.
  2. Stronger Oversight and Enforcement: Create an independent, empowered regulatory body with real power to investigate, impose significant penalties, and ensure timely resolution of complaints. Regular, proactive audits of marketing expenses, strong whistleblower protection, and, crucially, publicly naming companies and professionals found guilty are vital for accountability. Inspired by global best practices such as the US Physician Payments Sunshine Act, which mandates public disclosure of payments to healthcare providers, this level of transparency is critical. Better coordination between the DoP, National Medical Commission (NMC), Income Tax Department, and Competition Commission is also essential.
  3. Empower Doctors and Promote Ethics: Medical schools must focus more on ethical practice. The NMC and State Medical Councils must consistently act against doctors who break rules. Encouraging doctors to prescribe generic drugs and supporting independent medical education are key steps.
  4. Industry Must Adapt to Real Regulation: While industry associations can support compliance, the primary responsibility for enforcement must shift from self-regulation to an external, statutory body. Companies must be mandated to comply, not just encouraged.
  5. Educate the Public: Inform people about their rights, how marketing can influence prescriptions, and the importance of generic alternatives. Also, encourage reporting of misleading drug ads.

Conclusion:

The path to ethical pharmaceutical marketing in India is challenging but vital. It needs a united effort from the government, regulators, drug companies, doctors, and the public. The June 19, 2025, revelations, as brought forth by The Economic Times, serve as a critical turning point. By committing to transform the UCPMP into a fully statutory and robustly enforced framework through the vital steps outlined above, we can effectively turn the bitter pill of malpractices into the sweet success of ethical healthcare, laying a crucial groundwork for a healthier, more prosperous, and truly developed ‘Viksit Bharat’ by 2047.

By: Tapan J. Ray

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

 

 

UCPMP: Vacillating Between ‘The Perfect’ And ‘The Real’ World?

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In the ‘perfect world’ one takes ‘perfect decisions’, while in the ‘real world’ one takes a ‘real decision’ – as the saying goes. In tandem, a raging debate continues on what is ‘perfect’ and what is ‘real’, in the world we live in today. This may cause a dilemma to many, which seems to be all pervasive today. Understandably, many critical industry practices and processes are also a part of this quagmire. The pharma industry, the world over, including India, is no exception, where such dilemma and debates span across virtually all the business domains of the industry.

However, in this article, I shall focus only on one specific issue – alleged pharma marketing malpractices that continue unabated, regardless of severe punitive measures in many cases, from several parts of the world. Has it then become a universal ‘culture’ in this area? For greater clarity, let me start the ball rolling by trying to understand the line that differentiates ‘the perfect world’ norms from ‘the real world’ ones.

Understanding the ‘line’ between the ‘Perfect World’ and the ‘Real World’:

I reckon, in ‘the perfect world’ people develop ideal values, ethical standards and practices. The social, business and economic environments also encourage and promote an uncompromising value system that culminates into perfect and desirable behavioral traits for all. Consequently, there are no grey areas in the ethics and value judgement, especially regarding what is ‘right’ and what is ‘wrong’.

Whereas, in ‘real world’, the surrounding social, business and economic environment usually encourages and promotes self-serving interests, mostly from the shelter of ‘perfect world,’ as we shall see later. There also appears to be a flexibility in the overall value system – drawn around different guidelines, for preferred behavior and practices in most spheres of life. Consequently, one can spot many grey areas in that space, which are subject to different interpretation by different people. ‘Exceptions’ to the preferred behavior are also many.

As construed by many, one contemporary and broad example could perhaps be, the ethics, values and governance – enshrined in the Indian Constitution, arguably belong to the ‘perfect world.’ The same for ‘the real world’ is, what the majority of the population, including those who are governing the country demonstrate through words, deeds and action on the ground.

Living in ‘the real world’ – most expect others to practice ‘the perfect world’ norms:

Although, most people, including several different entities, actually prefer to live in ‘the real world,’ following commensurate practices and exceptions – generally expect others to practice ‘the perfect world’ norms – following commensurate ethics and values. Governments usually, try to exhibit that they want all citizens to be in ‘the perfect world’. However, under pressure of different nature, their policy enforcement arms keep maintain the status-quo of ‘the real world.’

Let me illustrate this point from the Indian perspective, with some recent examples related to the prevailing Uniform Code of Pharmaceutical Marketing Practices (UCPMP) in the country. Here itself, we shall find, even the Government machinery vacillating between the both worlds.

Government vacillating between ‘both worlds’:

A recent media report related to the ongoing allegation on pharma marketing malpractices in India raised a controversy. It reported, on January 13, 2020 – ‘PM Modi warns pharma companies not to bribe doctors with women, foreign trips and gadgets,’ during his meeting with the senior officials from top drug-makers. This move was, reportedly, triggered by the report of “Support for Advocacy and Training to Health (SATHI)” – an NGO.

Prior to this, on May 03, 2018, it was also widely reported, “Prime Minister Narendra Modi recently opened a Pandora’s box by condemning the allopathic doctors of the country during an interaction called ‘Bharat ki Baat, Sab ke Saath’ with the diaspora in London. The PM condemned the Indian doctors on charges of corruption and malpractice. He emphasized on the doctor-industry nexus and shared concerns on the fallout of such a relationship.”

The above statements, as reported, reflect deep anguish of the Prime Minister for violation of ethics and values in pharma marketing practices – as expected in the ‘Perfect World.’ Following this outburst at the top echelon of the country’s governance hierarchy, the logical general expectation is, commensurate action by the Department of Pharmaceuticals (DoP), at least, to contain those contentious practices.

But, the Government seems to be vacillating: 

Instead, just after a few weeks from what was quoted in the above January 2020 report – on February 09, 2020 another media report highlighted something that confirms vacillation of the Indian Government from ‘the perfect world’ to ‘the real world’, albeit too frequently, on this issue.

Despite UCPMP being in force for all drug companies to abide by, voluntarily, since January 2015, the situation in this area hasn’t improved a bit, which the DoP also seems to be well aware of. The obvious question, therefore, that follows: Is the DoP on the same page as PM Modi?

Interestingly, despite the PM’s assertion in this regard, the DoP Secretary, reportedly, kept playing the same old tune even after 5 years of the UCPMP’s unsuccessful implementation. He again repeated: “We have strictly instructed all the stakeholders to follow the code voluntarily. If not complied seriously, the department will bring in stricter regulations at the time to come and also think about making it mandatory for effective compliance.” This threat, from the ‘perfect world’ perspective, continues with the ‘real world’ understanding for action.

The possible reason for the above vacillation:

Many consider, intense lobbying by the pharma associations as the possible reason for vacillation of the Government. This is vindicated by another report of January 17, 2020 that claimed, a powerful Indian industry association has sought multiple tweaks in the current UCPMP – meant for voluntary implementation by the drug industry in India. Two of these, among several others, were reported as follows:

  • Relaxed rules for the distribution of free samples.
  • Permission for doctors to work at pharmaceutical companies.

As reported, this proposal of the industry has been floated among pharmaceutical companies, for comments. ‘Once approved by all member companies, it will be sent to Department of Pharmaceuticals secretary P.D. Vaghela.’ However, it appears, there doesn’t seem to be anything new in it, as news archives reveal, similar proposals were submitted by the Indian drug industry associations, in the past, as well.

At this stage, let me hasten to add that the above January 2020 report, quoting the Indian PM’s anguish, was denied by a domestic industry association by a statement.

The first report was denied – albeit vaguely – by an industry association:

Curiously, the January 2020 report was denied by the domestic Industry Association - Indian Pharmaceutical Alliance (IPA) by releasing a statement. It said, the meeting convened by the Prime Minister Narendra Modi with the healthcare industry on January 01, 2020 was to discuss future road map for growth of the industry.

It further emphasized, the focus of the discussion was to promote research and development, build an innovation ecosystem, improve access to high-quality medicine and strengthen global competitiveness of the industry. The purpose was to take the industry to the next level and leverage opportunities going forward in the pharmaceutical sector. “There was no discussion on uniform code of pharmaceutical marketing practice in the meeting,” the statement added.

However, this statement appears rather vague to many, as it doesn’t emphatically deny that the PM did not say or mean those words, regardless of the context. Neither, the PMO, reportedly, has done so, as yet.

Probably because of this reason, another news article reported on January 15, 2020 that the Indian Medical Association, the country’s largest body of doctors, urged Prime Minister Narendra Modi to “prove, deny, or apologize (for)” the purported statement attributed to him asking pharmaceutical companies ‘not to bribe doctors with foreign trips, gadgets and women.’ I am still not aware of any response from the PMO on the same. Hence, some people find the industry association’s statement, especially considering the core issue under discussion today, albeit vague.

Some key findings on UCPMP:

Be that as it may, as I indicated in one of my previous articles in this blog, a survey report by Ernst and Young titled, “Pharmaceutical marketing: ethical and responsible conduct”, was released in September 2011 on the UCMP and MCI guidelines. It highlighted some of the following points:

  • More than 50 percent of the respondents are of the opinion that the UCPMP may lead to manipulation in recording of actual sampling activity.
  • Over 50 percent of the respondents indicated that the effectiveness of the code would be very low in the absence of legislative support provided to the UCPMP committee.
  • 90 percent of the respondents felt that pharma companies in India should focus on building a robust internal control system to ensure compliance with the UCPMP.
  • 72 percent of the respondents felt that the MCI did not stringently enforce its medical ethics guidelines.
  • Just 36 percent of the respondents felt that the MCI’s guidelines would have an impact on the overall sales of pharma companies.

Although, this report may be a bit dated, its key findings don’t seem to have changed much as on date. It is also worth noting that there are umpteen examples of similar malpractices in the pharma industry, globally.

Conclusion:

“Compared to a strictly controlled manufacturing environment, the marketing environment for the pharmaceutical industry in India is less regulated, but will move towards greater regulation in times to come”, predicted ‘The Global Guide to Pharma Marketing Codes,’ a few years ago. The situation remains unchanged.

Alongside controversy over pharma firms allegedly ‘bribing’ medical professionals, the Alliance of Doctors for Ethical Healthcare (ADEH), a network of doctors from across the country has demanded that the UCPMP framed five years ago be made mandatory, as another media report highlighted on January 21, 2020.

But the reality is, the Government wants the drug industry to follow ‘the perfect world’ ethics and values in marketing practices to safeguard patients all round interest. Whereas, the drug industry wants the policy makers to appreciate the business compulsions of ‘the real world’ and introduce exceptions to the rules.

Both the stances are unlikely to meet a common ground, because general population expects the Government to adhere to ethics and values of ‘the perfect world’, in health care. Whereas, in public, pharma industry leaders often take vows of practicing so, but seem to act differently in ‘the real world’ situation, expanding the credibility gap.

In the perceivable future, it appears unlikely that the Government’s ‘perfect world’ expectations, and the ‘real world’ actions of most pharma players will be in sync with each other. Unless, of course, either the Government moves away from ‘the real world’ marketing ethics and values – safeguarding patient interest, to meet ‘real world’ expectations of the industry, or make pharma players to fall in line with ‘the perfect world’ expectance, by making the UCPMP mandatory.

Is the question, therefore, how to take a ‘perfect world’ decision for the people’s health interest, in the ‘real world’ of the pharma industry? Till this issue is resolved, UCPMP will continue to exist, but no more than a ‘toothless tiger’, as it were.

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.

 

 

Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India

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“Bottle Of Lies Exposes The Dark Side Of The Generic-Drug Boom” – re-emphasized the book, released in May 2019.  This confirms, the raging debate on the questionable quality of many generic drugs manufactured in India and involving several top domestic pharma companies, is a never-ending one. Numerous articles also ascribe many different reasons to this saga, leaving an overall impression – as if, blindfolded persons are trying to describe an elephant, touching and feeling different parts of the animal’s body, each at a time.

Let me illustrate the point with the Bloomberg article of January 31, 2019. It reported, “Culture of ‘Bending Rules’ in India Challenges U.S. Drug Agency.” And further commented: ‘The FDA confronts creative improvisation in the world’s largest generic-drug exporter.’ Curiously, according to the above report it seems to be a general belief among many, even within India.

This article will take into account the above apprehension – specifically raised against Indian drug manufacturers of both branded and non-branded generics. Accordingly, my focus will be on just three points – as possible causative factors for this critical issue:

  • Is it an India specific concern – thus related to ‘Indian cultural mindset’? or it’s a global issue, involving both Indian multinational drug manufacturers.
  • Is it a systematic attempt to create a perception bias against low-cost generic drugs, worldwide?
  • Are generic drug makers resorting to such unacceptable shortcuts due to increasing margin pressure?

Having deliberated these points, I shall try to outline a set possible remedial measures to address this issue in a holistic way, ensuring a win-win outcome. Let me first explore, whether or not this issue is specific to India, involving Indian drug manufacturers.

Is the issue India specific?

Is the issue of questionable quality of generic drugs, irrespective of whether they carry a brand name or not restricted to the shores of India? One can find its answer in the same report, as quoted above. A yearlong investigation by Bloomberg News into the generic-drug industry concluded, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’

One possible reason for such perception could be, since India is predominantly a branded generic market, voices decrying ‘questionable’ safety and efficacy of cheaper non-branded generic drugs, are too loud. Nevertheless, amidst all this, who’s who of branded generic manufacturers continue getting caught on the wrong foot by overseas regulators in the quality quagmire. Ironically, multinationals are also included in it.

Multinationals are also included in such quality quagmire:

There are several examples of non-compliance to requisite drug quality standards by multinational drug companies. Let me illustrate the point with an example that involves a top global pharma player.

The March 04, 2019 ‘Warning Letter’ of US-FDA for the Irungattukottai (Tamil Nadu) plant of Pfizer in India, clearly said: “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture.”

This is not a solitary example of Pfizer’s generic hospital injectables manufactured in this plant. According to a media report dated July 17, 2018, twice before US-FDA had cited manufacturing and testing issues in this facility, containing 11 observations of the regulator, such as, workers “manipulated test sample weights to obtain passing results” for both batches of raw materials and finished product. It is a different matter that the company, later on, decided to close this plant for commercial reasons. Be that as it may, negative perception of generic drug quality is indeed an issue that needs to be addressed without further delay, holistically.

Studies have captured negative perception of generic drugs:

That this is a perception, has been well – elucidated along with its implications, in several studies. A few of which are as below:

A BMJ article concluded: “A significant proportion of doctors, pharmacists and lay people hold negative perceptions of generic medicines. It is likely these attitudes present barriers to the wider use of generics.” It further added, “Negative perceptions of medicine quality along with other drivers contribute towards choosing more expensive medicines in the private sector.”

Endorsing this point, yet another BMJ article inferred: “Negative perceptions of generic medicines and preferential promotion of branded medicines over generics by pharmaceutical companies could influence prescriber behavior and affect trust in healthcare provided in public services. To succeed, access to medicine programs need to systematically invest in information on the quality of medicines and develop strategies to build trust in healthcare offered in government health services.”

Again, in a separate survey of over 2700 physicians on perceptions of generic drugs, more than 23 percent of respondents expressed negative perceptions about their efficacy and nearly 50 percent. reported negative perceptions of generic drug quality. In the same survey, patients also expressed concerns that the lower cost of generics is associated with reduced medication quality.

Although, the above survey was conducted in the United States, the current situation in India, I reckon, is no different, but with one caveat. Here, preferential promotion of branded generic medicines over cheaper non-branded equivalents, by the respective drug manufacturers, could significantly influence prescriber behavior. Therefore, the question that follows: Is this perception-creation based on facts?

Is the negative perception fact-based?

Although, even the US-FDA clearly states that: ‘A generic medicine works in the same way and provides the same clinical benefit as its brand-name version”, I did try to find some conclusive evidence depicting brand name drugs are superior to their cheaper generic equivalents. While doing literature searches, two types of results emerged – there are studies that do not find any significant difference between generic drugs and their branded equivalents. At the same time, a few other studies do suggest that there is a difference between these two, but admitting that these studies are not conclusive. Let me give below examples of each.

No quality difference found between generic drugs and the branded variants: 

I shall quote here three studies, out of which one is India specific. The analysis reported in the above BMJ article, found that ‘the generic and branded variants of the medicines tested were of comparable quality.’

Another study, published by PLOS Medicine on March 13, 2019 also said, “In this study of 8 drug products conducted using 2 large US commercial insurance databases, we observed that use of generics provided comparable clinical outcomes as the brand products.”

An India specific researchon the same also reported, most generic and branded drug users believed that their drugs were effective in controlling their ailments with no significant difference in reported adverse effects and drug adherence.

Slightly different results were also reported with generics, but not conclusive:

One such study questioned, whether generic drugs are truly equivalent to the brand-name versions.This article was published on January 2019 by Harvard Health Publishing with the title, “Do generic drugs compromise on quality?”

This article quoted a Canadian study, published in the October 2017 issue of ‘Circulation: Cardiovascular Quality and Outcomes’, which found that patients who took generic versions of three different blood pressure medications in the months after the generic drugs became available saw increased rates of drug-related side effects.

Was it due to a perception bias?

To ascertain whether or not there is a perception bias, let us look into the following details of the same study along with its conclusion.

In this study, the researchers ‘looked at the numbers of emergency room visits and hospitalizations for 136,177 individuals ages 66 and over (60% of them women) who used any of three blood pressure medications: losartan (U.S. brand name Cozaar), valsartan (Diovan), and candesartan (Atacand). The investigators examined data for the periods 24 months before and 12 months after the generic versions of these medications went on the market. And found that before the generic versions became available, about one in 10 people taking the blood pressure drugs had to go to the emergency room or be hospitalized each month. In the month after each of the generics went into use, the rates of these adverse events went up: 8% for losartan, almost 12% for valsartan, and 14% for candesartan.’ The study authors commented, this might suggest performance differences between the brand-name and generic drugs.

However, analyzing this study, the Harvard article suggested further probe on the question: Did it result from quality problems with the generic versions of these medications or were there other factors that occurred in this time frame?

Another research, aimed at finding, whether patients are more adherent to generic statins than brand-name statins (lovastatin, pravastatin, or simvastatin) and whether greater adherence improves health outcomes, also concluded, “An 8% reduction in the rate of the clinical outcome was observed among patients in the generic group versus those in the brand-name group.” This also wasn’t a conclusive one, either.

Nevertheless, the key point of a ‘perception bias’, is captured in a separate study, where the researchers did find higher rates of psychiatric hospitalization for patients taking generic and AG escitalopram and sertraline, compared with those who initiated the brand-name product. Importantly, they noted that these outcomes were likely due to either residual confounding or generic perception bias.

No quality difference also found between branded and non-branded generics in India:

There are studies, which captured no quality difference between branded generics and non-branded generics in the country. One such India specific study concluded: “Quality of branded-generics is same as for their branded version. The study highlights the need to modify the drug price policy, regulate the markups in the generic supply chain, conduct and widely publicize the quality testing of generics for awareness of all stakeholders.”

Thus, so far, we have seen in this article that concern on quality of generic drugs is neither India specific, nor is it related to ‘Indian cultural mindset.’ And this is, undoubtedly, a global issue, involving both Indian and multinational drug manufacturers. There are also ample evidences available that a systematic attempt is being made to create a perception bias against low-cost generic drugs, worldwide. Let us now look at the third possible causative factor, as I listed above.

Is it due to margin pressure on generic drugs?

The answer to this question was deliberated in an article titled, ‘Generic drug makers feel pinch as prices crumble,’ published in the Financial Times on August 17, 2017. Quoting a top global financial analyst, it reported – global generic drug industry, where Indian manufacturers are major players,has maintained roughly 30 per cent operating margins over a long period of time, with improvements year on year. But, since last few years, there has been a margin degradation, which may possibly further go down – even lower than what it is today.

The article further highlighted, a round of consolidation among their main customers in the US: the wholesalers, have escalated the problem.  Many of these groups have clubbed together to form “mega buyers”, known as general purchasing organizations, that can command large discounts. Moreover, for the US market, another area of ‘concern’ is that the US-FDA has identified boosting competition in the generics market as one of its main priorities. As this reform opens up, it could squeeze the generic drug margins further.

Many envisage that intense cost cutting measures, could have transgressed in the drug quality assurance area, aggravating this issue. Although, it needs to be verified through credible studies, curiously, some signs of improvement in this area has recently been reported.

That said, there appears to be a strange coincidence between recent reports on Indian drug makers showing improvement in USFDA inspection outcomes and attempts to increase generic drug companies and some of their top executives slapped with price-fixing lawsuits in the U.S.This needs to be studied further.

The way forward:

The negative perception of generic drugs, in general, and non-branded generic drugs, in particular, is most likely a well-crafted business issue, rather than a genuine patient safety concern. It calls for an immediate two-pronged approach:

  • Vigorous awareness and educational campaigns on safety and efficacy of generic drugs targeted to patients, medical and paramedical professionals.
  • New regulatory measures, especially the following five:

- No pricing pressure or price control in any form of generic drugs

- Abolish brand names for generic drugs

- Make generic prescription compulsory to boost intense competition and thereby     reducing the price.

- Restrict the number of ingredients in FDC not more than two or three

- Make Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory.

Conclusion:

Thus, the questionable quality of generic drugs is not an India specific concern and involves both Indian multinational drug manufacturers. This is also evident from the analysis, as quoted above, that underscores, ‘FDA inspections at factories from West Virginia to China have found reason to doubt the data meant to prove drugs are safe and effective.’ Many studies have revealed that there is a systematic attempt to create a perception bias against low-cost generic drugs, worldwide.

A sequence of remedial measures, as described above, also include fostering competition, instead of introducing government controls on prices of generic drugs with stringent regulatory oversight being in place.

Thus, the so called ‘belief’ that the ‘culture of bending Rules’ is culpable for dubious generic drug quality in India, is more akin to a strong perception, prevailing in India, rather than based on any scientific analysis related to this issue. This ought to change with a well-coordinated intervention – for patients’ health interest sake.

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.

Are Cancer Patients Victims of Pharma’s Payment to Doctors – For Prescriptions?

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In pharma industry, people of all socioeconomic backgrounds have no other choice but to visit doctors, to seek their expert advice for medical treatment. Patients expect them to prescribe the right and most affordable medicines for desired relief. Ironically, it appears to be the general industry practice to favorably influence the prescribing decision of doctors of all kinds of drugs, irrespective of any tangible product superiority, and price. This practice has been a decade old general concern of many that still continues unabated, especially in India.

There is nothing wrong, though, in pharma companies’ influencing doctors with unique product and associated service offerings over others, intended to benefit patients. However, when any marketing activity goes against the general patient interest, or may be construed independently as short-changing patients, must not be condoned, the least by any government.

This article will discuss how this menace is not sparing even those cancer patients who can’t afford expensive drugs but want to survive. I shall start with an overall perspective and sign off with the prevailing situation in India.

Are such practices transparent?

Obviously not, as these take place under several benign names and guise, and is an open secret to almost all stakeholders, including many patients. In several countries, India excluded, the government or the legal systems have intervened to make the drug marketing process more transparent, often with strong punitive measures. Curiously, adequate space is constantly being created by some players to hoodwink all these.

Today, one can, at best put two and two together to get a feel of what could possibly be the reality. It still remains a challenge to exactly quantify as to what extent it is going on, and with what impact on common patients, who mostly pay out of pocket to purchase medicines. But the good news is, studies on this particular subject has commenced, a few examples of which I shall in this article.

Some common influencing tools:

Pharma companies’ influencing tools for favorable doctors’ prescriptions are, apparently, directly proportional to a doctor’s prescription generating capacity. Once a doctor is influenced by such mechanism, high product price becomes irrelevant, even for those who find the drug difficult to afford.

The form of influence varies from gifts carrying different price tags, advertising in specific souvenirs or journals, sponsoring medical symposia of doctors’ choice, to arranging company’s own ‘Continuing Medical Education (CME)’ programs in exotic places, with travel, boarding and lodging expenses paid by the company, sometimes including their spouses. Hefty speaking, consulting fees and research grants may also be among these influencing tools. All are commonly done through a third party to avoid easy detection.

Some evidences of drug companies’ payment to doctors:

May 02, 2017 edition of the Journal of American Medical Association, published a couple of survey findings that can be summarized, as follows:

  • About half of U.S. doctors received payments from the pharmaceutical and medical device industries in 2015, amounting to USD 2.4 billion
  • Such payments and gifts very likely encourage doctors to prescribe pricey brand-name drugs and devices pushed by sales representatives.
  • Chances of receiving a general payment depended on the doctor’s specialty — 61 percent of surgeons got a payment, compared with 48 percent of primary care doctors.
  • Pharma companies earned more than USD 60 billion in 2010 for brand-name drugs included in the study. Generic drugs are 80 to 85 percent less expensive, which means hospitals can save lots of money, if doctors start prescribing generics instead of brand-name drugs.
  • Doctors at academic medical centers were more likely to prescribe cheaper generic drugs than expensive brand-name drugs after their hospitals adopted rules that restricted pharmaceutical sales visits, the researchers said.
  • “Many doctors would say they can’t be bought for the low amounts we’re talking about, but the amounts actually aren’t that low. Many, many doctors are getting thousands of dollars. It’s hard to imagine that is not influential,” the article underscored.

Quantification of increased prescription:

Another interesting study analyzed the prescription pattern of cardiologists who were taken out for a meal by sales representatives of Pfizer or AstraZeneca– makers of two expensive branded cholesterol-lowering statins, Lipitor and Crestor. They found that payment to physicians increases prescribing of the focal drug by 73 percent.

It is noteworthy,during the time period examined, which was between 2011 and 2012, there were several equivalent, lower-cost generic statin drugs available in the market. The paper’s findings confirm the general belief that drug companies’ business practices do influence doctors prescribing behavior while treating patients, in favor of the high-cost targeted brands.

Any relationship between soaring cancer drug price and pay for prescriptions?

Dr. Peter Bach at the Memorial Sloan-Kettering in New York City, with the help of a ‘cancer drug price chart from 1965 to 2016 period, established that treatment cost with cancer drugs is soaring. In another article, on the same issue, Dr. Bach commented: ‘Market pricing does not ensure access to new innovation.’ He reiterated:‘Profit maximizing price is not welfare maximizing. This is a policy failure, not a market failure.’

So far so good. However, everybody was surprised when on October 02, 2018, The New York Times reported about the same Memorial Sloan-Kettering that: ‘Dr. Craig B. Thompson, the hospital’s chief executive, resigned in October from the board of Merck. The company, which makes the blockbuster cancer drug Keytruda, had paid him about $300,000 in 2017 for his service.’

The same report further detailed: ‘Dr. Thompson, 65, received $300,000 in compensation from Merck in 2017, according to company financial filings. He was paid $70,000 in cash by Charles River in 2017, plus $215,050 in stock.’ This does not seem to be a solitary example from this hospital, as ‘another article detailed how a hospital vice president held a nearly $1.4 million stake in a newly public company as compensation for representing Memorial Sloan Kettering on its board.’

The question that arises now, how would such behavior of doctors adversely impact cancer patients’ health-interest? This was evaluated in an interesting article, as below.

Evaluation of association between industry payment to doctors and their prescribing practices:

Financial relationships between physicians and the pharmaceutical industry are common. This was analyzed in detail with deft and expertise in yet another very recent research paper titled, ‘Evaluating the Strength of the Association Between Industry Payments and Prescribing Practices in Oncology,’ published in the ‘The Oncologist’ on February 06, 2019. Two critical findings of the study may interest many, which are:

  • The association between industry payments and cancer drug prescribing was greatest among physicians who received payments consistently (within each calendar year).
  • Receipt of payments for compensation purposes, such as for consulting or travel, and higher dollar value of payments were also associated with increased prescribing.

Its implication on cancer patients:

To ascertain its implication on cancer patients by combining records of industry gifts with prescribing records, the study identified:

  • The consistency of payments over time, the dollar value of payments, and payments for compensation as factors.
  • This is very likely to strengthen the association between receiving payments and increased prescribing of that company’s cancer drug.

The outrageous cost of cancer treatment with innovative drugs:

As I said in my previous articles, new cancer drugs are increasingly becoming more innovative with greater efficacy. The fact that the 2018 Nobel Prize in Physiology or Medicine was awarded to James P. Allison and Tasuku Honjo “for their discovery of cancer therapy by inhibition of negative immune regulation,” provides a testimony to the high quality of innovation involved in the discovery and development of cancer therapy.

This progress is excellent, unquestionably! But who is getting benefitted by these innovative cancer medicines? The headline of the article, titled ‘The Nobel Prize is a reminder of the outrageous cost of curing cancer,’ published by the Vox Media Vox Media on October 02, 2018, captures the prevailing reality, succinctly. Articulating, ‘The Nobel Prize is a reminder of the outrageous cost of curing cancer,’ the author further elaborates the point. The paper underscores, for the first time ever, we’re living in a moment when many of our most promising medical advances, such as cancer immunotherapy, are far out of reach for the vast majority of people who could benefit from them.

Innovative cancer drugs are pricey only for the high cost of innovation? 

Let me deliberate this point based on data. Quite expectedly, pharma industry never accepts that prescriptions are bought. But, when get caught, they retort that these are some aberrations, keeping their much-publicized argument unchanged in support of jaw dropping cancer drug prices. They argue, innovative drugs are brought to market after incurring R&D expenditure of over a billion dollars, if not more.

The Vox article quotes the CEO of Novartis, the maker of the immunotherapy drug Kymriah, saying that the R&D costs of the drug were about USD 1 billion. But many experts don’t buy this argument. The article echoed one such expert - Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania’s Perelman School of Medicine.

The professor countered by saying: ‘That’s certainly a big investment, but it is much less astounding when compared with the drug’s anticipated revenue. Based on Kymriah’s list price, treating just 2,700 patients would allow Novartis to recoup its entire investment. Even with significant discounts for many patients, it wouldn’t take many treatments to turn a considerable profit.’

According to researchers at the University of Pennsylvania, the total cost for removing, reprogramming and infusing the cells into each patient is less than USD 60,000—just one-sixth of the USD 373,000 price tag. Production costs do not seem to be driving the stratospheric drug prices, the researchers commented.

Has any remedial action been taken by the industry or the doctors?

Except one report, I reckon, this practice continues virtually unabated, even today.

‘The above conflicts at Memorial Sloan Kettering, unearthed by The New York Times and ProPublica, have had a rippling effect on other leading cancer institutions across the country’, commented ProPublica on January 11, 2019. It reported: ‘The cancer center will now bar top officials from sitting on outside boards of for-profit companies and is conducting a wide-scale review of other policies.’

Further, Dana-Farber Cancer Institute in Boston and Fred Hutchinson Cancer Research Center in Seattle, both of whose executives sit on corporate boards, are among the institutions reconsidering their policies on financial ties, the article said.

Conclusion:

Although, in many countries, at least, some action has been taken by the governments to curb such practices by framing appropriate laws, in India it is virtually free for all types of situation, as prevailing in this area.

A recent news report aptly summarized the Indian situation. It highlighted: “While Prime Minister Narendra Modi recently mocked doctors in a public interaction in London for going on foreign trips sponsored by pharma companies, his government has been unsuccessful in bringing in a law to punish pharma companies that bribe doctors. The Uniform Code of Pharmaceutical Marketing Practices (UCPMP), prepared by the pharmaceuticals department (DoP) to control unethical marketing practices in pharma has been in the work since December 2014, six months after the current government came to power. More than three years later, the code is stuck in the Niti Aayog after the law ministry rejected DoP’s draft.”

With the above global and local perspective, I reckon, even if some changes take place in the developed world, India is unlikely to fall in that category, any time soon. Consequently, a large number of Indian patients may continue to fall victims of common pharma practice – pay to doctors for prescriptions. It doesn’t seem to matter even for cancer drugs.

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.

Uniting Pharma With Business Ethics: A Bridge Too Far?

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Operating ethically not only is the right thing to do but also is fundamental to success in business. Poor governance and poor ethical business practices can lead to fines, public scrutiny and distrust – overshadowing good performance, destroying reputation, and undermining the morale and engagement of employees. …We must act in ways that build and maintain the trust of patients, healthcare professionals, governments and society. This was articulated in the Novartis Corporate Responsibility Report 2017, highlighting how important it is to unite pharma operations with business ethics for each company. But is it happening in reality?

The same question haunts yet again with the announcement of a new Code of Marketing Practice by the International Federation of Pharmaceutical Manufacturers and Associations’ (IFPMA),effective January 2019. The pronouncement prescribes ‘a global ban on gifts and promotional aids for prescription drugs wherever the association’s member companies operate.’

However, the overall scenario gets more complex to comprehend, when on January 03, 2019  Bloomberg Law reported: ‘The change is causing concern among both U.S.-based and multinational companies like Astra Zeneca, Bristol-Myers Squib, Johnson & Johnson, and Pfizer Inc. about how to balance appropriate business behavior with respect for cultural norms in other countries.’ Interestingly, the IFPMA membership virtually covers all MNC drug companies, operating across the world. Thus, any concern on its implementation, especiallyamong some of the bigger names, raises more questions than answers about its effectiveness. What exactly has been the outcome of all such actions being taken, especially by the multinational pharma industry associations, from time to time. Have the patients been benefited – at all?

Keeping this recent development as the backdrop, I shall try to gauge in this article, is the bridge still too far to mitigate the widening gap between overall pharma operations and the standard of business ethics -voluntary code of practices of pharma associations notwithstanding?

Why pharma ‘business-practices’ and ‘business-ethics’ are so important?

Before charting onto the sensitive areas of ‘business practices’ and ‘business ethics’, let me recapitulate the meaning of these two terminologies to fathom why these are so important in pharma to protect patient health interest.

  • Business practice is defined as a method, procedure, process, or rule employed or followed by a company in pursuit of achieving its objectives. Itmay also refer to these collectively.
  • Similarly, Business ethics is defined as a form of professional ethics that examines the ethical and moral principles and problems that arise in a business environment. It applies to all aspects of business conduct on behalf of both individuals and the entire company.

Thus, ethical business policies and practices for pharma industry, when worked out both by an industry association or an individual company, aims at addressing potentially controversial issues, such as corporate governance, insider trading, bribery, discrimination, corporate responsibility and fiduciary responsibilities.

Ironically, despite well-hyped announcements of voluntary codes of practices from time to time, no commensurate changes in patients’ health interest are visible in real life. Thus, the very relevance of such edicts is now being seriously questioned by many.

What do reports reflect on ongoing pharma business practices?

To get an idea in this area, let me quote below from three reports, out of which one is specifically on the Indian scenario, which has not changed much even today:

“The interaction between physicians and medical representatives (MRs) through gift offering is a common cause for conflicts of interest for physicians that negatively influence pre- scribing behaviors of physicians throughout the world.” This was articulated in an article titled, “Gift Acceptance and Its Effect on Prescribing Behavior among Iraqi Specialist Physicians”, published by Scientific Research Publishing (SCIRP) in June 2014.

A couple of years before that, on September 07, 2012, Reuters also published an article with the headline: “In India, gift-giving drives drug makers’ marketing.” Thereafter, many similar articles were published in various newspapers and magazines, possibly to trigger remedial action by the regulators in the country.

Very recently, on January 18, 2019, The New York Times (NYT) came out with a mind boggling headline – “Study Links Drug Maker Gifts for Doctors to More Overdose Deaths.” Elaborating on this JAMA study, the NYT wrote: “Counties where the doctors got more meals, trips and consulting fees from opioid makers had higher overdose deaths involving prescription opioids.”

The point I want to drive home here is that freebies in the form of gifts, travel to exotic places with free meals and stay, fees of various types clubbed under a mysterious nomenclature ‘consulting fees’, purported to influence doctor’s prescribing behavior, are now rampant. These are adversely impacting patients, as they are often compelled to buy high-priced drugs, unnecessary drugs, including antibiotics, sedatives and opioids, to name a few.

Are big pharma companies following the codes – both in letter and spirit?

The doubt that surfaces, are these changes just for displaying to the stakeholders how well and with stringent measures, drug companies are self-regulating themselves, on an ongoing basis? Before jumping to any conclusion, let us try to make out whether, at least the big pharma players are following these codes in both letter and spirit.

To establish the point, instead of providing a long list of large pharma settlements with governments for various malpractices, I shall cite just the following two relatively recent ‘novel’ examples related two top global pharma companies, for you to have your own inferences.

  • The first one is related to reports that flashed across the world in May 2018 related to Novartis. One such article described, “Congress demands info from Novartis about its USD 1.2m in outflows to Michael Cohen, just as it was negotiating payments for its cancer drug.” The report further elaborated, Novartis’ USD 1.2 million payment was made in the shell company of Michael Cohen, President Donald Trump’s personal lawyer and so-called ‘fixer’.
  • The second one is the September 13, 2018 report of The New York Times. It revealed: ‘Dr. José Baselga, the chief medical officer of Memorial Sloan Kettering Cancer Center, resigned on Thursday amid reports that he had failed to disclose millions of dollars in payments from health care companies in dozens of research articles.”

The report also stated: “Dr. Baselga, a prominent figure in the world of cancer research, omitted his financial ties to companies like the Swiss drugmaker Roche and several small biotech startups in prestigious medical publications like The New England Journal of Medicine and The Lancet. He also failed to disclose any company affiliations in articles he published in the journal Cancer Discovery, for which he serves as one of two editors in chief.”

Indian companies aren’t trailing far behind, either:

Many Indian companies are, apparently, sailing on the same boat. Let me illustrate this point by citing an example related to India’s top ranked domestic pharma player.

What it said: Way back on November 13, 2010, Sun Pharmain a communication expressed its concern by saying: ‘Over four decades since Independence, the government nurtured a largely self-sufficient pharma industry. But the entry of MNCs is putting most drugs beyond the reach of millions.’

The communique further added: ‘Even as the domestic industry begins to feel the heat of an unprotected market, public health experts are examining why drug prices in India are higher than in Sri Lanka, which imports most of its drugs. The MNC takeover raises the specter of an MNC-dominated pharma sector selling drugs at un-affordable prices, a throw ‘back to the scenario just after Independence, which the government painstakingly changed over four decades. Are we setting the clock back on the country’s health security?’

The reality thereafter: It’s a different story that today, the same Sun Pharma, despite alleged ‘high price drugs of MNCs’, occupies the top ranking in the Indian pharmaceutical market. Be that as it may, the point to note that the same company is now facing similar charges from other countries, almost a decade after. On March 2017, a media report came with a headline: ‘Sun Pharma, Mylan face price fixing probe in US.’

Incidentally,the company is mired with allegation on governance related issues, as well. A media report dated November 20, 2018 carried a headline: ‘Governance cloud over Sun Pharma, stock at 6-month low.’ This example is quite relevant to this discussion, as well, for its link with ethical business practices, as discussed earlier.

Additionally, class-action lawsuits in the United States for alleged business malpractices, including ‘pay for delay conspiracies’, against Indian pharma companies are also on the rise – Sun Pharma and Dr. Reddy’s top the list in terms of those who face most class-action litigation, reported a leading Indian business daily on September 02, 2017.

Pharma malpractices continue, DOP is still to make UCPMP mandatory: 

In this quagmire, where self-regulation doesn’t work, the government usually steps in, as happened in the United States and Europe. Whereas, in India, no decisive government action is yet visible to curb this menace, especially for protection of patients’ health interest. Let me try to illustrate this point with the following chronology of four key events:

  • On May 08, 2012, the Parliamentary Standing in its 58th Report, strongly indicted the DoP for not taking any tangible action in this regard to contain ‘huge promotional costs and the resultant add-on impact on medicine prices’.
  • Ultimately, effective January 01, 2015, the Department of Pharmaceuticals (DOP) put in place the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) for voluntary implementation, despite knowing it has not worked anywhere in that format.
  • When voluntary UCPMP did not work, on September 20, 2016, the then secretary of the DoP reportedly said, the mandatory “UCPMP is in the last leg of clearance with the government. The draft guidance has incorporated suggestions of the pharma industry and other stakeholders.”
  • After another year passed by, on April 16, 2018, a news report reconfirmed: ‘4 years on, code to punish pharma firms for bribing doctors still in works.’ Its status remains unchanged till date.

Conclusion:

Even after Prime Minister Modi’s comment on April 2018 regarding the alleged nexus between doctors and pharmaceutical firms and doctors attending conferences abroad to promote these companies, decision paralysis of DOP continues on this important issue.

Pharma companies continue practicing what they deem necessary to further their business interest, alongside, of course, announcing their new and newer voluntary codes of practices. But, patients keep suffering, apparently for the apathy of the DOP to curb such malpractices forthwith.

Coming back to where I started from, when the malice is so deeply rooted, would any global ban ‘brand-reminders’, such as gifts, even if implemented religiously, work? Thus, the doubt lingers, for uniting pharma operations with corporate business ethics is the bridge still too far?

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.

Patients’ Trust And Pharma Remain Strange Bedfellows?

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Like many other industries, pharmaceutical companies too often talk about improving focus on effective ‘stakeholder-relationship management’. The doctors obviously form an integral part of this process. There is nothing wrong with it. Nevertheless, serious concern of ‘conflict of interest’ between the two entities is being raised on the means adopted to achieve the targeted end results.

Much as the drug makers expect that these methods are easily justifiable and would not bother anyone, it usually doesn’t happen that way, especially among the informed patients. When patient-interest gets compromised in this complex transactional web, the residual impact is awfully negative. Over a period of time, such episodes lead to a patient-doctor trust-gap, having a snowballing effect on the integral constituent of this saga – the pharma industry.

In this article, I shall briefly explore the scale and depth of such trust-gap and try to fathom who can effectively address this cancerous spread. This initiative when implemented well, won’t just protect patients’ health interest, ensuring affordable health care of good quality for all. It will also help rejuvenate pharma players’ declining reputation, facilitating long-term business interest –unchained by too many stifling regulations.  

For being in the paradise of health care…

‘Trust’ is the bedrock of any meaningful relationship and is usually built based on one’s experience, perception and feelings, besides a few other factors. It falls apart in the presence of deception or lies, even if these are well camouflaged. Similarly, clandestine acts when unearthed could also lead to the same outcome. The charted pathways for development or collapse of patients’ trust regarding doctors, or government policy makers trust towards pharma players are fundamentally no different.

In a scenario where patients can trust doctors for suggesting the best affordable treatment of good quality, including safe and effective drugs; hospitals and caregivers are just and conscientious; insurance companies are caring and fair in their dealings; drug prices are rational; published clinical trial reports on drug efficacy and safety are unbiased, the communication from pharma companies are trustworthy without any hidden agenda – we are living in the paradise of health care.

Nonetheless, the same paradise built on patients’ valuable trust would get shattered, as the drug regulators and the media get to know and unearth lies and clandestine dealings between doctors and pharma companies. Patients soon realize, though the hard way that they are being short-changed. A trust-gap is created, giving rise to an avoidable vicious cycle in the healthcare space. It is difficult to break, as one witness today, but not impossible, either.

The trust-gap is all pervasive:

Although, we are discussing here the trust-gap between doctors and drug companies on the one hand, and patients, drug policy makers and the regulators on the other – the trust-gap is all pervasive. This is vindicated by a startling headline of the January 16, 2018 edition of a leading Indian business daily. It says: “Over 92% people don’t trust the health care system in India: Study”.

It quotes the GOQii India Fit 2018 report saying a large part of which includes doctors, hospitals, pharma, insurance companies and diagnostic labs. The following table shows the ranking of some these constituents in terms of trust gap of Indians.

Rank Healthcare system People don’t trust (%)
1. Hospitals 74
2. Pharma companies 62.8
3. Insurance companies 62.8
4. Medical clinics 52.6
5. Doctors 50.6
6. Diagnostic Labs 46.1

The survey emphasizes that a series of failure, particularly the negligence of hospitals in the recent past has made it hard to trust in the system. The lack of transparency was the other reason that stands out.

Not a recent phenomenon, but increasing:

A trust-deficit in the healthcare system isn’t a recent phenomenon. This was corroborated in the article, titled ‘Doctors, patients, and the drug industry: Partners, friends, or foes?’ It was published almost a decade ago – in the February 07, 2009 edition (Volume 338) of the British Medical Journal (BMJ). The authors quoted a contemporary report issued by the ‘Royal College of Physicians’, which captured an all-time low relationship between the drug industry, academia, healthcare professionals, and patients, even at that time. The paper suggested that it is in the interests of all parties to bridge the trust-gap, without further delay.

As mentioned before, this particular discussion will focus on just two areas – pharma companies and the doctors – not all constituents of the health care system. This is primarily to have a congruity with my previous discussion on the importance of ‘perception’ in pharma. From that perspective, it is evident from the BMJ paper that a trust-gap exists not just in the doctor-patient relationship, but also between the drug policy makers and the pharma industry. I shall try to drive home this point with the following two examples.

 A. The trust-gap in doctor-patient relationships for ‘Conflict of Interests’:

The article titled, “Conflict of Interest in Medicine” featuring in the JAMA Network on May 02, 2017 described ‘Conflict of Interest’ as ‘a situation in which a person is or appears to be at risk of acting in a biased way because of personal interests.’

The article further elaborated thatdoctors’ relationships with drug companies (including any payments or gifts received from the companies) might affect how they report the results of research studies, what they teach medical students about particular drugs, or what treatments they recommend for patients. Moreover, doctors may preferentially refer patients to those diagnostic facilities for tests that may financially benefit them for doing so.

B. The trust gap between the government policy makers and the pharma industry:

That such trust-deficit is all pervasive, gets reverberated even through the speeches of no less than the Prime Minister of India.

On April 18, 2018, during an interactive session of theBharat Ki Baat, Sabka Saath‘ diaspora event at the Central Hall in Westminster, UK, Prime Minister Modi,reportedly said that doctors visit Singapore and Dubai to attend conferences, and not because someone is sick. “The pharma companies invite them for that. To finally break the resultant sale of expensive medicines, the government has launched generic stores where medicines of similar quality are sold at cheaper prices” – the PM further added during his interaction with the audience present in this function at London.

As expected, the medical community in India expressed displeasure over the remark of the PM on doctors and pharma companies on a foreign soil, the same media report highlighted.

Interestingly, just a year ago, on April 17, 2017, while inaugurating a hospital in Surat, a home to several top Indian generic drug makers Prime Minister Modi had said: “We are going to make legal arrangements to ensure that when doctors write prescriptions they write that generic medicines are sufficient and that there is no need for any other medicine.”

Some ineffective interventions:

As I said before, this downward spiral with a widening trust-gap in the healthcare space of the country needs to be arrested soon, with effective steps. The best remedial measure in such cases will obviously be self-regulation by all concerned, keeping patients’ interest at the center.

As an antidote to this problem, in the previous Government regime, ‘Uniform Code of Pharmaceutical Marketing Practices (UCPMP)’ was put in place, but only for voluntary implementation by the drug companies.

Enough time has elapsed in experimenting with this process, since then. Regrettably, like many other countries, self-regulation in this area to address the malady of trust deficit hasn’t worked in India too. Both the ‘Professional Conduct and Ethics’ of Medical Council of India (MCI) for doctors, and the UCPMP of the Department of Pharmaceuticals (DoP) for drug companies intended to address the so-called doctor-pharma industry unholy nexus, have not yielded expected results. The saga continues, unabated.

Conclusion:

From the patient-interest perspective, what is happening today in the global healthcare space is indeed baffling. Improving access to good quality, affordable drugs for all, has become a challenge in many countries, just as in India. Consequently, alleged unholy doctor-industry nexus that contributes a significant part to this problem, is attracting greater public attention today. The issue is being often raised even at the highest echelon of the incumbent government. But, more puzzling is, even after the PM’s public anguish, the DoP doesn’t seem to have walked the talk. Much hyped – the proposed mandatory UCPMP has not yet seen the light of the day, despite a clear indication of the same.

The question then arises, what happens if it does not happen due to political or any other compulsions? In that case, I reckon, the primary initiative to bridge the existing trust-gap, should rest on pharma companies. They may not always agree with all public allegations leveled against them, as the creator of this ungodly collaboration, and rightly so. Nonetheless, remaining in a perpetual denial mode in this regard, won’t help the pharma industry, anymore. More so, when the number of net-savvy, reasonably well-informed and globally connected patient groups, are fast increasing. Besides being fair in all business transactions, drug players need to sincerely engage with patients, not in usual condescending ways, but with due respect, for mutual benefits.

Otherwise, despite pharma industry and patients being interdependent in so many ways, sans a strict regulatory framework with legal teeth, ‘patients’ trust’ and ‘pharma’ will continue to remain uneasy, if not strange bedfellows.

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.

Should ‘Pharma Marketing’ Be In The Line of Fire?

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Close to half a century ago, Peter Drucker – the Management Guru wrote: As the purpose of business is to create customers, any business enterprise has two basic functions: marketing and innovation. Drucker’s concept is so fundamental in nature that it will possibly never change, ever.

That innovation is the lifeblood of pharma industry is well-accepted by most people, if not all. However, when similar discussion focuses on pharma marketing, the industry virtually exposes itself in the line of fire, apparently from all directions. This trend, coupled with a few more in other areas, is making a significant dent in the reputation of the pharma industry, triggering a chain of events that create a strong headwind for business growth.

The consequences of such dent in pharma reputation get well-reflected in an article titled “How Pharma Can Fix Its Reputation and Its Business at the Same Time,” published in the Harvard Business Review (HBR) on February 3, 2017. The author observed:

“This worrisome mix of little growth potential and low reputation is the main explanation for why investors are increasingly interested in how pharma companies manage access-to-medicine opportunities and risks, which range from developing new treatments for neglected populations and pricing existing products at affordable levels to avoiding corruption and price collusion.”

On the above backdrop, this article will try to explore the relevance of Drucker’s ‘marketing’ concept in the pharma business – dispassionately. Alongside, I shall also deliberate on the possibility of a general misunderstanding, or misinterpretation of facts related to ‘pharma marketing’ activities, as these are today.

Communicating the intrinsic value of medications:

Moving in this direction, let me recapitulate what ‘pharma marketing’ generally does for the patients – through the doctors.

Despite being lifeblood that carries the intrinsic value of a medication from research lab to manufacturing plants and finally to patients, ‘pharma marketing’ is, unfortunately under incessant public criticism. It continues to happen, regardless of the fact that one of the key responsibilities of pharma players is to disseminate information on their drugs to the doctors, for the benefits of patients.

One may justifiably question any ‘marketing practice’ that is not patient-friendly. However, the importance of ‘marketing’ in the pharma business can’t just be wished away – for patients’ sake.

Way back in 1994, the article titled, “The role and value of pharmaceutical marketing” captured its relevance, aptly articulated:

“Pharmaceutical marketing is the last element of an information continuum, where research concepts are transformed into practical therapeutic tools and where information is progressively layered and made more useful to the health care system. Thus, transfer of information to physicians through marketing is a crucial element of pharmaceutical innovation. By providing an informed choice of carefully characterized agents, marketing assists physicians in matching drug therapy to individual patient needs. Pharmaceutical marketing is presently the most organized and comprehensive information system for updating physicians about the availability, safety, efficacy, hazards, and techniques of using medicines.”

The above relevance of ‘pharma marketing’, whether globally or locally, remains unchanged, even today, and would remain so, at least, in the foreseeable future.

It’s a serious business:

As many would know, in many respect ‘pharma marketing’, especially of complex small and large molecules, is quite a different ball game, altogether. It’s markedly different from marketing activities in most other industries, including Fast Moving Consumer Goods (FMCG), where customers and consumers are generally the same.

In contrast, in prescription drug market customers are not the consumers. In fact, most consumers of any prescription medicine don’t really know much, either about the drugs or their prices. They get to know about their costs while actually paying for those directly or indirectly. Healthcare providers, mostly in those countries that provide Universal Healthcare (UHC) in any form, may also be customers for the drug manufacturers. Even Direct to Consumer (DTC) drug advertisements, such as in the United States, can’t result into a direct choice for self-medication, other than Over the Counter (OTC) drugs.

Additionally, pharma market is highly regulated with a plethora of Do’s and Don’ts, unlike most other industries. Thus, for the drug manufacturers, medical professionals are the real customers, whereas patients are the consumers of medicines, as and when prescribed by doctors.

With this perspective, ‘Pharma marketing’ assumes a critical importance. It is too serious a strategic business process to be jettisoned by any. There exists a fundamental responsibility for the drug manufacturers to communicate important information on various aspects of drugs to individual physicians, in the interest of patients. This has to happen, regardless of any controversy in this regard, though the type of communication platforms, contents used and the degree of leveraging technology in this process may widely vary from company to company.

Assuming that the marketing practices followed by the industry players would be ethical and the regulators keep a strict vigil on the same, effective marketing of a large number of competing molecules or similar brand increases competition, significantly. In that process, it should ultimately enable physicians to prescribe drugs that will suit each patient the most, in every way. There can’t possibly be any other alternative to this concept.

A common allegation:

Despite these, a common allegation against ‘pharma marketing’ keeps gathering momentum. Reports continue pouring in that pharma companies spend far more on marketing drugs than on developing them. One such example is a stinging article, published by the BBC News on November 6, 2014.

Quoting various published reports as evidence, this article highlighted that – 9 out of 10 large pharma players spend more on marketing than R&D. These examples are generally construed as testimony for the profiteering motive of the pharma companies.

Is the reason necessarily so?

As any other knowledge-based industry, effective communication process of complex product information with precision, to highly knowledgeable medical professionals individually, obviously makes pharma marketing cost commensurately high. If the entire process of marketing remains fair, ethical and patient centric, such costs may get well-neutralized by the benefits accrued from the medicines, including lesser cost of drugs driven by high competition.

Further, a successful pharma marketing campaign is the ultimate tool that ensures a reasonable return on investments for further fund allocation, although in varying degree, to offer more new drugs to patients – both innovative and generics.

Marketing decision-support data generation is also cost-intensive:

Achieving short, medium and long-term growth objectives are as fundamental in pharma as in any other business. This prompts that investments made on ‘pharma marketing’, fetch commensurate returns, year after year. To succeed in this report, one of the prime requirements is to ensure that the content, platform and ultimate delivery of the product communication is based on current and credible research data having statistical significance.

With increasing brand proliferation, especially in competing molecules or branded generic market, arriving at cutting-edge brand differentiation has also become more challenging than ever before. Nevertheless, identification of well-differentiated patient-centric product value offerings will always remain ‘a must’ for any persuasive brand communication to be effective.

It calls for generating a vast amount of custom made decision-support data on each aspect of ‘pharma marketing’, such as target market, target patients, target doctors, competitive environment, differential value offering, and scores of others. The key to success in this effort is to come out with that ‘rare commodity’ that separates men from the boys. This is cost intensive.

What ails pharma marketing, then?

So far so good –  the real issue is not, therefore, whether ‘pharma marketing’ deserves to be in the line of fire. The raging debate on what ails ‘pharma marketing’ should primarily focus on – how to ensure that this process remains ethical and fair, for all.

Thus, when criticism mounts on related issues, it may not necessarily mean that ‘marketing’ is avoidable in the pharma business. Quite often, critics do mix-up between the crucial ‘importance of pharma marketing’ and ‘malpractices in pharma marketing.’ Consequently, public impressions take shape, believing that the pharma marketing expenses are generally higher due to malpractices with profiteering motives.

As a result, we come across reports that draw public attention with conclusions like: “Imagine an industry that generates higher profit margins than any other and is no stranger to multi-billion dollar fines for malpractice.”

A similar article published ‘Forbes’ on February 18, 2015 also reiterates: “The deterioration of pharma’s reputation comes from several sources, not the least of which is the staggering amount of criminal behavior that has resulted in billions of dollars’ worth of fines levied against the industry.”

One cannot deny these reports – lock, stock and barrel, either. Several such articles named many large pharma players, both global and local.

Conclusion:

In my view, only pharma marketers with a ‘can do’ resolve will be able to initiate a change in this avoidable perception. No-one else possibly can do so with a total success in the foreseeable future – not even the requirement of a strict compliance with any mandatory code having legal teeth, such as mandatory compliance of the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) that the Indian Government is currently mulling.

I guess so because, after a strong deterrent like mandatory UCPMP is put in place, if reports on marketing malpractices continue to surface, it will invite more intense public criticism against ‘pharma marketing’ – pushing the industry’s reputation further downhill, much faster.

Be that as it may, it’s high time for all to realize, just because some pharma players resort to malpractices, the ‘pharma marketing’ process, as such, doesn’t deserve to be in the line of fire – in any way.

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.