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

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

“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.”

…continue reading…

Focus On Patient Compliance To Boost Pharma Sales…And More…

Focus On Patient Compliance To Boost Pharma Sales…And More…

One high-impact area in the healthcare space that often finds its place in the backseat is – patient noncompliance. A term that is commonly used in regard to ‘a patient who does not take a prescribed medication or follow a prescribed course of treatment.’ It comes with a steep price, for causing serious adverse impact not just on human health and health system, but also in the pharma business. Intriguingly, such incidents are still not scientifically monitored enough and vigorously acted upon, both globally and locally.

The World Health Organization (W.H.O) has also flagged it as a huge problem, as it reports, 10 percent to 25 percent of hospital and nursing home admissions result from patient noncompliance. Furthermore, about 50 percent of prescriptions filled for chronic diseases are not taken correctly, with 40 percent of patients not adhering to the treatment regimen.

In this article, just after giving a flavor to its financial cost to patients, I shall dwell mostly on its impact on the pharma players, as overcoming this important problem doesn’t generally fall in the area of strategic focus for most of them. Finally, I shall explore how drug manufacturers can translate this problem into an opportunity – as the third growth driver for business, creating a win-win situation for all.

Economic and health impact on patients:

Noncompliant patients suffering from both acute and chronic ailments, pay a heavy price, not just in terms of longer suffering arising out of complications, but also incurring significantly more health expenditure for treatment of the same diseases. According to IMS Institute for Healthcare Informatics, on average, less than 40 percent of patients around the world are fully complying with their treatment instructions.

Even in the Indian context, the problem is no different. Let me illustrate the point with the example of a chronic disease, such as Asthma. The article published on June 26, 2018 in ‘Lung India’ – the official publication of Indian Chest Society reported: “The mean annual direct costs among compliant and non-compliant patients were ₹14, 401 and ₹24, 407, respectively. Percentage of hospitalization was less among the compliant group (6 percent) when compared with noncompliant group (17 percent).”

The study concluded, asthma is not only associated with patient-specific impairment, but also creates a significant economic burden for the family and society. The major contributors to the burden are the medication cost and hospital admissions. Patient compliance with prescribed drugs can help keep asthma under control, thereby decreasing the economic burden and emergency hospital admissions – avoiding the economic risk from ill health with high out of pocket payments.  Productivity loss is another under-appreciated source of economic loss contributing to indirect cost. The rising costs of investigations, interventions, and treatment of chronic diseases further complicate the problem.

Economic impact on pharma business:

According to November 16, 2016 report, published by Capgemini and HealthPrize Technologies, globally, annual pharmaceutical revenue losses had increased from USD 564 billion in 2012 to USD 637 billion due to non-adherence to medications for chronic conditions. This works out to 59 percent of the USD 1.1 trillion in total global pharmaceutical revenue in 2015.

The report highlights,…continue reading….

Is Pharma Communication In Sync With Doctors’ Expectations?

Is Pharma Communication In Sync With Doctors’ Expectations?

Not many pharma companies, especially in India, undertake any ongoing data-based analysis to gain insight on expectations and change in behavioral pattern of their customers, particularly doctors and patients. Many developments are taken as obvious, such as, when busy practitioners don’t want to give much time to a medical rep for brand detailing, if not any time, common spontaneous inference remains – ‘they are too busy.’ These responses are mostly without any data backup. Thus, meaningful efforts in finding ‘productive alternatives’ continue to remain elusive.

As making personal calls to some top medical practitioners becoming increasingly difficult, non-personal outreach for them tend to significantly go up. It often happens without any quantifiable assessment of how each of these targeted doctors is responding to even the non-personal outreach of the company.

That this is happening, was captured in a world-wide survey by ZS Associates in 2016. It highlighted: ‘The number of digital and non-personal contacts that the pharmaceutical industry now has with physicians exceeded its number of sales rep visits to doctor offices.’ It is worth repeating, this finding comes from a global survey.

Lack of insight in this area, could give rise to an avoidable disconnect between many pharma company’s core communication strategy, and what individual doctors would like to hear from them and in what way. Unless this issue is addressed sooner, it could be a strong invisible barrier to brands’ success, if not the image, too. Thus, in this article, I shall explore its implication, the key factors driving this trend, and most importantly, how to bridge this gap. Let me start with the well-established trend of increasing volume of non-personal contacts and hasten to add, by ‘non-personal’ I mean situations where a person is not physically present.

Increasing volume of non- personal outreach:  

In these days, personal interaction of medical reps with doctors, despite being traditionally important, is just one of the many channels for delivering requisite content to them. With increasing difficulty in getting top prescribers’ time, for effective brand detailing, many more non-personal channels are fast opening up.

Today, even in the Indian context, more than half of the total outreach volume of many drug companies, especially to such prescribers, are taking place through non-personal promotions. These include activities, such as:

• Both, general and personalized e-mails
• Mobile alerts to achieve various different objectives
• E-detailing
• Continuing Medical Education (CME)
• Speaker program with associated arrangements and fees
• Sponsoring medical events, seminars, symposia
• Advertising in medical journals

Whereas, a little less than 50 percent of the total outreach by volume, still take place through in-person interactions with medical reps for brand detailing, as studies indicate. Interestingly, for known products, such contacts are often no more than just brand reminders.

The productivity of such calls needs to be measured and quantified, just as what is required for various non-personal channels, including digital – the contact volume of which is fast increasing for several companies. Curiously, despite this prevailing scenario and in some cases, a declining performance trend notwithstanding, higher promotional budgets continue to be available, based on hope and supported by optimistic forecasts.

The key reason attributed to this trend:

The article titled ‘What healthcare professionals want from pharma’, published in …continue reading…

Creating Satisfied Patients Begins With Developing Satisfied Employees

Creating Satisfied Patients Begins With Developing Satisfied Employees

‘The core issue in health care is the value of health care delivered,’ wrote Michael Porter in a paper titled, ‘Value-Based Health Care Delivery,’ published by the Institute of Strategy & Competitiveness of Harvard Business School (ISC-HBS) on January 15, 2014.

Building on this concept, EY in its 2018 edition of ‘New horizons: Executive insights on the future of health’ articulated: ‘Value-driven care means delivering the best clinical outcomes with optimized costs, while delivering a satisfying experience for patients and providers.’

Creating a ‘satisfying patient experience’ – or ‘satisfied patients’ for its brands, being the ultimate objective of a drug company, I shall add an interesting dimension to it, in this article. And that is: Will it necessitate creating satisfying employees within the organization to achieve this goal? To build a right perspective in this direction, let me begin with the core concept of Michael Porter on this subject. This starts with – what is generally regarded as ultimate ‘value’ to patients, in healthcare delivery?

Defining ultimate ‘value’ in health care delivery:

Porter defined this ‘value’ as ‘patient health outcomes per dollar spent’. He also made some key assertions in this context, which I am summarizing below:

• Delivering high and improving value is the fundamental purposeof health care.
• Value is the only goal that can unite the interestsof all system participants.
• Creating positive-sum competition on value for patients is fundamental to health care reform in every country.

Are these assertions attainable?

To create ‘Value-Based Health Care Delivery (VBH),’ the people would also need a ‘Value-Based Pharma Industry (VBP)’, delivering ‘Value-Based Medicine (VBM)’, for all. The three key principles for any VBM are considered as follows:

• Thoroughly selected values must be based on the best research evidence available and applied as treatment options. 

• Values for patients are converted into measurable utility values to facilitate the integration.

• The cost-utility level expected from selecting a particular treatment option is the basis for decision-making.

In other words, the whole purpose of offering a VBM is to provide cost effective, science-based healthcare that incorporates patient values. Nonetheless, effective implementation of both VBH and VBM would entail a radically different leadership mindset, with quite a different set of success requirements, both globally and locally.

To drive home this point, let me illustrate just the third point of the Porter’s model of VBH, as quoted above. This clearly articulates: ‘Creating positive-sum competition on value for patients is fundamental to health care reform in every country.’ But the current reality of ‘competition’ in the drug industry is far from what it should be, as evident from one of the Brookings studies.

How competitive is the pharma industry to reduce cost of health care?

The Brookings paper titled, ‘Enabling competition in pharmaceutical markets,’ published on May 02, 2017 shares its research findings on the subject, which in a broader context include the following points:…continue reading…