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

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June 11, 2025 — The Economic Times reports that a prominent pharmaceutical industry association has urged the Union Health Ministry to reconsider its directive that bars medical representatives (MRs) from physically meeting doctors in central government hospitals. The industry argues that the move could restrict vital information flow and undermine drug accessibility, especially in remote regions.

This reaction comes just days after the Directorate General of Health Services (DGHS), through a circular dated June 4, 2025, issued a policy prohibiting in-person MR interactions in government hospitals. Instead, it mandates that all product-related communication occur via digital means—email or secure portals.

While some may see this as a step toward dismantling the traditional MR role, that interpretation misses the point.

In my view, this is not about eliminating medical representatives. It’s about transforming their role to match the ethical, digital, and scientific expectations of modern healthcare.

A System Already Poised for Change:

For decades, medical reps have been the primary channel through which pharmaceutical companies reached doctors—armed with product samples, promotional material, and persuasion tactics. In a market dominated by branded generics, this model shaped prescribing patterns significantly.

But the rules of the game are changing.

Doctors today demand data, not just messaging. Patients expect affordability and transparency. Regulators are watching. And the public increasingly values ethics over incentives in medical decision-making.

The DGHS circular doesn’t disrupt an efficient system—it corrects an imbalance that had gone unaddressed for far too long.

The Realities Behind Branded Generics:

Branded generics – off-patent drugs sold under specific brand names – make up over 70% of India’s domestic pharma market. These are often promoted aggressively through MRs, which:

  • Reinforces prescriber loyalty to brands
  • Contributes to higher out-of-pocket costs for patients
  • Distorts rational prescribing by emphasizing brand recall over clinical evidence

While these drugs have expanded access, the promotional tactics surrounding them need a serious reset.

Patented Drugs and the Innovation Dilemma:

At the other end are patented drugs – cutting-edge, research-driven therapies. These often remain inaccessible due to cost, late launches, and barriers in public procurement.

India’s Section 3(d) of the Patent Act rightly filters out frivolous patents, curbing “evergreening” strategies. But challenges around access, affordability, and information persist—even with innovative treatments.

In both generics and patented drugs, the way pharma communicates with doctors has come under scrutiny – and rightfully so.

The DGHS Directive: A Paradigm Shift:

The DGHS ban marks a fundamental policy shift, especially in government healthcare institutions that serve millions. Its goals are clear:

  • Ensure doctors’ prescribing decisions remain scientifically neutral
  • Reduce brand-driven influence in public hospitals
  • Promote evidence-based and peer-reviewed sources of drug information

This is not an anti-industry move. It’s a pro-patient, pro-transparency, and pro-science correction.

Not the End – but the Reinvention – of Medical Reps:

Let me say it plainly:

This is not the end of medical representatives. It is the beginning of their evolution.

The policy signals that the old “brand-push” model is obsolete—but the need for credible, well-trained, scientifically literate pharma liaisons remains stronger than ever.

What the New MR Must Look Like:

  • From Pitch to Precision:
    Reps must transition from product promoters to scientific communicators—sharing real-world evidence, safety data, and treatment comparisons.
  • From Doorstep to Digital:
    With hospitals restricting physical visits, MRs must now master digital communication tools—email, webinars, and secure doctor platforms.
  • From Prescription Goals to Knowledge Sharing:
    Companies should measure reps on their ability to engage ethically, not push volume. Focus must shift to educational impact.
  • From Influence to Integrity:
    Upskilling in medical writing, therapeutic areas, and regulatory guidelines can reposition MRs as Medical Science Liaisons (MSLs) or digital medical educators.

Pharma’s Call to Action:

To thrive in this changing landscape, companies must:

  • Launch non-promotional CME programs
  • Organize hospital-approved scientific sessions
  • Build secure, compliant digital channels
  • Train MRs in ethical engagement, clinical literacy, and communication skills
  • Collaborate with medical councils and regulators to rebuild trust

Conclusion:

Industry resistance is expected. But clinging to outdated methods won’t work in a system demanding credibility over convenience.

The DGHS directive is not a crackdown. It’s a wake-up call. A moment to reflect, restructure, and reimagine how pharma and medicine should interact in a digital-first, ethics-forward India.

Medical representatives are not being shown the door. They are being shown a new direction—toward greater respect, responsibility, and relevance.

The future of pharma lies not in access at any cost, but in engagement with integrity.

By: Tapan J. Ray

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

 

AI: The New Elixir for Indian Pharma Brand Success

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India’s pharmaceutical market is a potent brew of complexity and opportunity. For new brands, including those in the branded generics space, success hinges on navigating this labyrinth effectively. Artificial Intelligence (AI) is emerging as the alchemist’s stone, capable of transforming market challenges into competitive advantages. This article outlines how pharma marketers can leverage AI to decode market dynamics, craft compelling brand stories, and deliver personalized experiences that fuel the launch of groundbreaking brands in India:

A. Unlocking Market Potential with AI:

  • Deep Dive into Data: AI’s analytical prowess uncovers hidden market segments, regional nuances, and emerging trends. For instance, by identifying untapped rural opportunities, brands can tailor offerings to resonate deeply with local needs.
  • Precision Patient Profiling: AI creates detailed patient personas, enabling hyper-targeted campaigns across multiple channels. This granularity ensures that every interaction is relevant and impactful.

B. Forging Brand Identity with AI:

  • Brand Alchemy: AI assists in crafting distinct brand personalities that captivate the target audience. By analyzing competitors and consumer sentiment, AI helps position brands effectively. 
  • Visual Brilliance: AI-powered design tools accelerate the creation of visually stunning brand identities, ensuring a cohesive look and feel across all touchpoints.
C. Crafting Compelling Narratives with AI:
  • Content Creation Catalyst: AI can help generate engaging content at scale, optimizing it for different platforms and audiences. This ensures a steady stream of relevant content without compromising quality. 
  • Language Mastery: In a linguistically diverse country like India, AI translates content seamlessly while preserving brand voice, reaching a wider audience.

D. Delivering Personalized Experiences with AI:

  • Predictive Powerhouse: AI anticipates customer needs and behaviors, enabling highly personalized campaigns. By understanding individual preferences, brands can deliver tailored experiences that build loyalty. 
  • Digital Dominance: AI optimizes digital advertising, ensuring maximum ROI. From precise targeting to effective bidding, AI drives results. 
  • Customer Centricity: AI analyzes prescriber data to identify high-value customers, enabling tailored interactions that strengthen relationships. 

E. Measuring and Maximizing Impact with AI:

  • Data-Driven Decisions: AI provides actionable insights into campaign performance, helping marketers optimize strategies in real-time.
  • Attribution Accuracy: By understanding the true impact of marketing channels, AI helps allocate resources effectively. 

Available examples of Global Pharma Giants: Pioneering AI in Marketing:

  • Personalized Precision: AstraZeneca leads the charge with AI-driven campaigns tailored to individual patient needs, delivering highly resonant messages. 
  • Content Creation at Scale: Pfizer’s AI-powered content engine churns out diverse, on-brand materials, boosting efficiency and engagement. 
  • Predictive Powerhouse: Novartis leverages AI to forecast market trends and optimize spending, maximizing ROI with data-driven precision.
  • AI-Driven Customer Care: Johnson & Johnson’s AI-powered chatbots enhance customer satisfaction by providing instant support and freeing up human agents for complex issues. 
  • Influencer Identification: Merck uses AI to discover and engage with key opinion leaders, building strong relationships through social media insights.
  • Market Intelligence Amplified: GSK harnesses AI to analyze vast datasets, uncovering unmet patient needs and informing product development. 
  • Sales Force Optimization: AbbVie employs AI to optimize sales routes and resource allocation, boosting efficiency and productivity. 

These global pharma leaders amply demonstrate the transformative power of AI in marketing. By understanding customers deeply, creating compelling content, and optimizing operations, they are driving sales growth and redefining industry standards. 

India’s Pharma Industry: Early Signs of AI Adoption:

While concrete examples of AI in Indian pharma marketing remain elusive due to competitive sensitivities, the industry’s trajectory suggests significant AI adoption. For instance, 

  • Cipla’s precision marketing efforts likely involve AI-driven targeting of specific patient segments.  
  • Sun Pharma’s pulse on patient sentiment is probably aided by AI-powered social listening.  
  • Dr. Reddy’s might be leveraging AI to predict regional demand patterns.

These are early indications of a broader AI trend in Indian pharma marketing. As the industry matures, more concrete examples are expected to emerge. 

Conclusion:

Against the above backdrop, I reckon, AI is not just a tool; it’s a strategic imperative today for pharma marketers in India. By embracing AI, brands can unlock new growth opportunities, strengthen brand equity, and ultimately, improve patient health outcomes.

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.

 

What Pays More: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drugs’?

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More innovative a drug is, the better is its business success rate. This was the general perception of around 92 percent pharma professionals in the past three years. Whereas the fact is: ‘Having the best product doesn’t guarantee sales anymore’. This was established by a research study of the ‘Bain & Company’ - covering multiple therapeutic areas, and was published on October 14, 2019.

It showed, when physicians prescribe a drug – its efficacy, safety and side-effect profile initially account for only 50 percent to 60 percent of the physician’s choice, with a declining trend over time. Interestingly, the other 40 percent to 50 percent of it, is based on a range of ‘physician and patient experience factors’, which pharma players need to target in innovative ways to differentiate their brands.

Many pharma companies are now experiencing the harsh reality that more innovative drugs, backed by traditional sales and marketing support are not yielding desirable financial returns. Head scratching has already started among astute pharma professionals to understand its reason for remedial measures. Thus, the number of executives who agreed with the above ‘Bain & Co’ study that: ‘Having the best product doesn’t guarantee sales anymore,’ increased to almost fourfold – from 8 percent to 28 percent in the next three years.

Thus, in this article, I shall explore whether innovation in creating a ‘unique patient experience’ during a disease treatment process, is as important, if not more than a ‘new drug innovation’. Curiously, high failure rate of most pharma players to innovate in this area, isn’t discussed as much as high failure rates in the development of innovative new drugs.

‘Customer service’ innovation – high failure rate – falling short of expectations:

Again, another article - ‘How Agile Is Powering Healthcare Innovation,’ published by ‘Bain & Company’ on June 20, 2019, brought out some interesting points related to this area. Let me quote a few of which as follows:

  • 65 percent of ‘customer-service innovation’ fall short of expectations of the target group.
  • The number of health care executives recognizing the need to respond quickly to changing customer-needs, has increased from 38 percent in the past three years to 60 percent for the next 3 years. But, most of them ‘lack the methodology, and even the language to implement it in practice.’
  • ‘Having the best product doesn’t guarantee sales anymore.’ Thus, healthcare companies face growing pressure to innovate in providing unique ‘customer experience’.
  • The critical point to note, customer needs evolve continuously, and leading companies respond rapidly with innovative new solutions catering to changing market demand.

As the core purpose of working for ‘customer-service innovation’ is linked with creating ‘brand loyalty’, let’s have a quick recap on ‘brand loyalty’ really means for pharmaceutical products, in today’s context.

‘Brand loyalty’ for pharmaceutical products in modern times:

There are many similar definitions of ‘brand loyalty’ for a pharmaceutical product. The research article – ‘Brand Loyalty as a Strategy for the Competition with Generic Drugs: Physicians Perspective,’ published in the Journal of Developing Drugs, on August 30, 2016, defined ‘brand loyalty,’ and articulated its advantages.‘ I am paraphrasing a few of which, as below:

  • The extent of the faithfulness to a particular brand, which is a major indicator of a long-term financial performance of companies.
  • The main advantages of brand loyalty can be defined as greater sales and revenue, a substantial entry barrier to competitors, increase in a company’s ability to respond to competitive threats and lower consumer price sensitivity.
  • ‘Brand loyalty’ can protect against price competition, including branded generics, as it gives confidence to physicians on the perceived effectiveness and safety of a brand – which they usually won’t be willing to compromise with for lower prices.

This brings us to a key question. Are traditional pharma methods of creating ‘brand loyalty’ getting replaced by the key consideration of creating a ‘unique customer experience’?

Creating ‘brand loyalty’ through ‘patient loyalty’ – a new equation:

It’s a fact today that traditional pharma methods of creating ‘brand loyalty’ is getting replaced by the key consideration of creating a ‘unique customer experience.’ This, in turn, is increasing the need of building ‘patient loyalty’, both for a pharma brand, as well as respective companies offering these brands. This is a new equation, where offering a ‘unique treatment experience’ to patients assumes a critical role more than ever before. This needs to be clearly understood by today’s pharma marketer, without any ambiguity.

In traditional pharma marketing, physicians remain, virtually, the sole focus of the branding exercise, as they appear to be the only decision makers of writing a brand prescription. Patients, in general, hardly used to have any role to play in that process. In this scenario, brand loyalty for the doctors – assuming the absence of any malpractices, is primarily driven by the following three much known factors:

  • Physicians’ unprejudiced buying-in a brand’s value offerings
  • Evaluation of opinion leaders and the doctors’ professional counterparts,
  • Quality of disease treatment outcomes.

Nevertheless, before getting into this area, let’s have a quick look at the primary drivers that pharma marketers have been using to boost financial performance of a brand.

Traditional sales boosters of a pharma brand:

The primary drivers that pharma marketers have been using to boost financial performance of a brand can broadly be classified as follows:

  • Multiple ways are followed to make important doctors write more prescriptions,
  • Increase the drug price, whenever an opportunity arises.

These factors still remain important, but aren’t just enough to deliver sustainable performance over a period of time. Thus, a new dimension needs to be added to it.

Add a new dimension to create brand and corporate loyalty:

With the emergence of increasingly more informed and demanding patients, there is a need to create a ‘loyal patient population’, by offering them primarily a ‘unique treatment experience’. And this is the new dimension.

For this purpose, off-the cuff approaches or strategies based on mere gut-feelings are unlikely to work. As I indicated in one of my articles, marketers need to acquire deep insights on their customers to make sales and marketing decisions more informed, than what it is today. Currently available state of the art technology can be a great enabler to facilitate this process.

This is easier said than done, because answering the question – how does a drug company create ‘brand loyalty’, is indeed a tough call. Nonetheless, many different industries have realized, since long, that offering a ‘unique customer experience’, is critical to create a pool of ‘loyal customers’.

I also had written earlier, pharma is still a late learner in accepting various new normal, in a holistic way. Accepting this reality, a sharp focus on creating ‘brand loyal doctors’ in various innovative ways, I reckon, will serve this purpose well. It’s only recently, a few companies have started working to offer such ‘experience’ to patients in the disease treatment process - end-to-end. Ironically, a large majority of them prefer to talk about it more than actually translating the same into reality.

Benefits of ‘brand loyalty’ through ‘unique customer experience’:

There are several advantages of building pharma ‘brand loyalty’ by offering ‘unique customer experience, without diluting the focus on ‘increasing prescription generation through doctors’. The benefits, I reckon, include, both new – innovative products and also branded generics. Let me give below one example of each:

  • Innovative new-products – positive word-of-mouth promotion: Satisfied patients having ‘unique end-to-end treatment experience’ with a new, innovative brand, are very likely to share it with others. This may be done by using different modes of communication, including various social-media platforms. This, in turn, may help both – add to take-off speed – post launch and create a snowballing impact on the brand adoption thereafter.
  • Branded generics – extend the product life cycle and increase growth: Patients who are loyal to a particular branded version of a generic molecule, are quite likely to refuse any change to a cheaper equivalent, even if recommended by the physician. Moreover, they will advocate for this brand to others, using different communication platforms, as indicated above. Continuation of this process will extend the life cycle of the branded-generic, with increasing growth and market share.

Conclusion:

Now, it’s time to get back to what we started with - What pays more: Creating ‘Innovative ‘Customer Experience’ Or ‘Innovative Drug?’ From the above perspective, it emerges that bringing innovative product to markets is, of course important. However, to ensure its sustainable financial success, other innovations, such as creating ‘a unique end-to-end patient experience’ with the brand, in all probability, would weigh more. This is an area which did not receive much attention for a long time, moving beyond the creation of increasing numbers of ‘brand loyal’ doctors, for business success.

Today, increasing consumerism in the health care space, besides pricing pressure, unfavorable perception and sinking image of the industry, is creating a strong headwind – impeding desirable growth of many pharma players. Such a challenging business scenario has prompted a few of them to innovate in designing a differentiated ‘customer experience’ – in a true sense.

Although, a large number of companies are talking about it, most are mere lip-services – a ground-swell in this area is yet to take place. The industry priority, in general, still weighs heavily in developing innovative products, and creating ‘brand loyal’ doctors, rather than cultivating ‘brand loyal patients’, alongside.

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.

‘Rigged’ Payment System Limits Biosimilar Access

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As often discussed, market entry of biosimilars, in general, brings a new hope not just for many patients, but also to biosimilar drug manufacturers – planning to get marketing approvals of these drugs in the United States, the El Dorado of global pharma industry.

Stakeholder expectations keep increasing manifold as biosimilars offer cheaper treatment options with biologic drugs in many life-threatening and rare diseases. However, biosimilars still remain an unfulfilled promise.

The January 2018 paper by Trinity Partners on “The State of US Biosimilars Market Access” in the largest drug market of the world makes an important observation in this regard. It says, the promise of biosimilars offering cost-saving competition in the lucrative US biologic market, remains largely unfulfilled.

As on date, adoption of biosimilars has been hindered by lack of market access due to complex contracting dynamics, besides regulatory and legal uncertainty, and a general lack of clinical comfort with biosimilars.

Consequently, current state of biosimilar acceptance and access appear too insignificant. More so, as compared to traditional small molecule generic markets where their use is fueled by automatic substitution and payer formularies, over higher priced branded reference drugs.

It would not have been difficult, especially for the innovative biologic drug makers to brush this important study aside, had the US-FDA Commissioner – Scott Gottlieb would not have voiced what he did in March this year.

With this perspective, I shall discuss in this article, how access to biosimilar drugs are getting limited. In doing so, I shall begin with what the US-FDA Commissioner has recently highlighted in this area.

Yet another barrier:

As reported by Bloomberg on March 07, 2018, the US-FDA Commissioner Scott Gottlieb unambiguously expressed that biologic drug manufacturers enter into exclusive arrangements with Pharmacy Benefit Managers (PBMs) and insurers, who agree to cover only the old brands in return for rebates or discounts. This “rigged” payment scheme might quite literally scare the biosimilar competition out of the market altogether, he articulated, categorically.

US-FDA Commissioner delivered this speech at the National Health Policy Conference for America’s Health Insurance Plans. During this deliberation, Gottlieb criticized some unwanted and avoidable practices that stifle biosimilar development.

He observed, of the 9 approved biosimilars in the US, only 3 could be launched market. In many instances, patent litigation is the reason for such delay in launch, post FDA approval. Connecting the dots, the Commissioner observed, even after being in the market, biosimilars continue facing more uncertainty due to a ‘rigged payment scheme.’

Started with a great promise:

It is worth noting, till 2010 no regulatory pathway for marketing approval of biosimilars was in place in the world’s largest pharma market – the United States. Hence, despite biosimilar drugs being a treatment option in many countries over the last two decades, the first biosimilar was launched in the US, following this pathway, only in 2015. It was Zarxio ((Filgrastim-sndz) of Novartis – indicated for the treatment of patients with acute myeloid leukemia (AML).

Since then, US-FDA has approved nine biosimilars. Ironically biosimilar market size still remains small and much below the general expectations. Most biosimilar manufacturers are navigating through multiple tough hurdles for market launch of this relatively new genre of complex drugs.

Navigating through tough hurdles:

There are tough hurdles to navigate through, while launching biosimilars, especially in the US. Some of which are as follows:

Protracted litigations: The development and launch of most biosimilars get stuck in the multiple patent web-lock, created around original biologic molecules, leading to long drawn expensive litigations.

Pricing: Following small molecule generic drugs, most payers and consumers expect biosimilar pricing too will be no different. However, in practice, most biosimilars are priced just around 15 percent to 20 percent less than original biologics.

Interchangeability: Lack of interchangeability among presently approved biosimilars in the US limits payers’ and consumer choice for a shift from the reference biologic drugs to suitable biosimilars. This virtually restricts the use of biosimilars mostly to such drug-naïve patients.

Confidence: For various reasons, the confidence and familiarity of both physicians and the consumers on biosimilars remain suboptimal. Whether relatively cheaper biosimilars can be used in the same indications as the reference biologic to the new patients – as an alternative choice, is still not clear to many of them. This situation calls for increasing awareness programs involving all stakeholders.

Manufacturing: The manufacturing process of large molecule biosimilars is quite costly as compared to small molecule generic drugs. Hence, these are unlikely to follow a similar pricing pattern, attracting as high a discount as around 80 percent, compared to original branded drugs.

Some of these barriers I have discussed in my article, titled ‘Improving Patient Access To Biosimilar Drugs: Two Key Barriers’, published in this blog on July 31, 2017.

Conclusion:

Be that as it may, drug manufacturers continue to see tremendous opportunity in biosimilars. The interest is heating up, as about six of the top 10 biologic drugs are expected to go off-patent in the US by 2019.

Despite all this, it is generally believed, the prevailing situation will change even in the US. The regulator is expected to facilitate smoother market entry of biosimilars, facing much less obstacles on the way. As many strongly believe, these are possibly an outcome of intense industry lobbying, with the high-level policy makers.  Many of these hurdles can be removed by the regulators, themselves, including drug interchangeability.

The US-FDA Commissioner Scott Gottlieb has already said in a meeting on March 07, 2018, the FDA will start educating doctors and patients to minimize clinical and other concerns related to biosimilars. Therefore, going forward, greater competition in the biosimilar space is expected to increase the long-awaited price differential, as compared to reference biologic.

With greater support from the regulators, biosimilars still show a unique promise of greater acceptance and access to patients – occasionally ‘Rigged’ maneuvers by the vested interests notwithstanding.

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.

Why Branded Generics Promise High Quality For Patients?

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Why most branded generic drugs don’t carry any stigma of quality, even when these are manufactured by small companies? The corollary to it is, why non-branded generics always carry a general stigma of inferior quality, even when produced by large Indian pharma companies?

While pondering over the answers to these questions, several other related facts also float at the top of mind, simultaneously, such as:

1. Just as many non-branded generics don’t go through the regular drug quality scrutiny of the regulators, branded generics are no different in this regard.

2. A large number of both branded and non-branded generics gets manufacturing approval by various State Drug Authorities.

3. The process of regulatory approval is exactly the same for both branded and non-branded generics. Even for branded generics regulatory approvals come only in the generic names and not with the brand names.

4. One can find hundreds of varieties of both branded and non-branded generics of the same molecules or of similar fixed dose combinations in the market.

5. Reports of substandard drugs of both non-branded and branded generics are also not significantly different.

6. Legal measures of reasonably stringent punishment in the country are no different between branded and non-branded generics.

This list is not exhaustive. Nevertheless, in this scenario, it is intriguing to fathom the reason of so much of contempt for non-branded generics within the industry, supported by a section of the media. This disgust gets invariably well-displayed as and when any serious discussion revolves around non-branded cheaper generic drug prescriptions in India.

Is it just a perception or based on solid facts?

This is a million-dollar question, but the optics is interesting. This also gets reflected in the recent media report on February 26, 2018. It writes, ‘The central government’s National Health Protection Scheme (NHPS) is going to put all of its focus on quality generic medicines, and not just the branded generic medicines, said Union Chemical and Fertilizer Minister Ananth Kumar while addressing a closed-door session with chief executives (CEOs) of pharmaceutical companies in Bengaluru on February 15.”

Curiously, in his statement the Minister also used the term ‘Quality’ only against non-branded generics and not against branded generics. Does it mean anything? If it does, is that just a perception or based on solid facts?

In this article, I shall try to assess why is this generally negative perception against cheaper non-branded generics gaining strength among many of us?

A general impression:  

An often-repeated fascinating argument is, branding of a generic drug is important as it will ensure high product quality. This reasoning persists, regardless of the fact that the Drug Controller General of India (DCGI) often makes public announcements to the contrary, as happened even recently.

Risks of NSQ drugs don’t lie solely on non-branded generics:

According to the ‘National Drug Survey, 2014-16’, conducted in association with the National Institute of Biologicals, out of the 47,012 samples tested from the country, 13 samples (0.0245 percent) were ‘Spurious’ and 1,850 samples (3.16 percent) were found ‘Not of Standard Quality (NSQ)’.

The data on 1,850 NSQ samples showed that these were from 569 manufacturing units. Of these, 10 percent of manufacturing units were responsible for about 50 percent of NSQ samples. Further, one third of total NSQ samples were from 22 manufacturing units.

Further, quoting the survey carried out through the National Institute of Biologicals, a September 04, 2017 media report also articulated: ‘During its recent survey, the drug regulator found well-known drug manufacturers failing quality tests. In the survey, samples tested from top drug companies were found not to be of standard quality.’

The names of some of these large drug manufacturers in India, including the multinationals, along with their smaller counterparts, appeared in the Public Notice of July 21, 2017 of the Central Drugs Standard Control Organization (CDSCO) of India. Thus, the risks of NSQ medicines can’t possibly be attributed solely to the small time non-branded generic drug manufacturers. This public notice is expected to draw attention of many stakeholders.

More facts:

On April 22, 2017, the Central Drugs Standard Control Organization (CDSCO) reported that popular branded drugs like D-Cold Total, Cetrizine, Combiflam, Panza-40 tablets, Ibuprofen, and antibiotics with ciprofloxacin, ofloxacin, Amoxycillin, Ciprofloxacin have tested sub-standard. Before this, media reports of July 8, 2016 highlighted, “The DCGI has again found Sanofi’s popular painkiller drug, Combiflam, of sub-standard quality, in its latest test last month. It had found the same defect in the medicine in February and April, too.’

Conclusion:

Considering these facts, it is difficult to comprehend why branded generic drugs, irrespective of who manufacturers, will be of high quality perceptually – always. Conversely, non-branded generic drugs, even when manufactured by a reputed manufacturer, say for example – Cipla, are perceptually no good for patients, in terms of quality standard.

Nevertheless, the hard facts indicate, quality is a general issue both for branded and non-branded generic drugs in India, and not particularly for the later one.

This brings me back to where I started from: Do Branded Generics Promise High Quality for Patients? To find the right answer to this question, one should look at the scientific data on the same – sans any perception. Otherwise, it becomes ‘your view’ versus ‘my view’ sort of a mindless, though a highly passionate debate.

I shall refrain from being judgmental in this area. The readers may wish to ponder over it, seriously, and arrive at a well-considered inference on the very basis of this discourse – from the patients’ perspective.

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.

Marketing Practices: Why Pharma Does What It Does?

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It started way back – spanning across many developed countries of the world. However, probably for the first time in the last five years, an international media group focused on this issue thriving in India, with so much detail.

Reuters reported it with a headline “In India, gift-giving drives drug makers’ marketing.” The report was supported by a detailed description of the relevant events, with ‘naming and shaming’. It drew the attention of some, apparently including the Department of Pharmaceuticals (DoP), but escaped the attention of many, and finally – got faded away with time, without any reported official investigation.

In this article, I shall revisit this subject against the backdrop of draft pharma policy 2017. My focus will be on the current marketing practices, with the moot question ‘why pharma does what it does’ occupying the center stage of this piece.

Bothering many across the world:

Pharma marketing practices wear different hues and shades. Many of these are contentious, and often perceived as gross ‘malpractices’. Nevertheless, across the world, these have mostly become an integral part of pharma business. Many law-enforcing authorities, including in the US, Europe, Japan and even China, have started taking tough penal action against those transgressions. Interestingly, the draft pharma policy 2017 intends to take this raging bull by its horn, with a multi-pronged approach, as I see it.

It’s a different debate, though, whether the policy makers should bring the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) under the Essential Commodities Act, or the Drugs and Cosmetics Act of India. Let’s wait and see what exactly transpires in scripting the final version of the new National Pharma Policy to address this issue, comprehensively.

The net impact of the fast evolving ‘newer norms’ of pharma ‘marketing’ practices, has been bothering a large section of the society, including the Governments, for quite some time. Consequently, many top-quality research studies are now being carried out to ascertain the magnitude of this problem. The top ranked pharma market in the world – the United States (US) are leading the way with such analysis. However, I haven’t come across similar India-specific analytical reports, just yet, probably due to lack of enough credible data sources.

Four recent studies:

Several interesting studies supported by a robust database have been carried out in the US during 2016 and 2017 to ascertain whether any direct relationship exists between payments in various forms made to the doctors by the pharmaceutical companies and physicians’ prescribing various drugs in brand names. For better understanding of this issue, I am quoting below, as examples, the gist of just four of such studies:

One of these studies conducted by ProPublica was published in March 2016. It found that physicians in five common medical specialties who accepted, at least one industry payment were more likely to prescribe higher rates of brand-name drugs than physicians who did not receive any payments. More interestingly, the doctors receiving larger payments had a higher brand-name prescribing rate, on an average. Additionally, the type of payment also made a difference: those who received meals alone from companies had a higher rate of brand-name prescribing than physicians receiving no payments, and those who accepted speaking payments had a higher rate of the same than those drawing other types of payments.

The details of the second study published in PLOS on May 16, 2016 states, “While distribution and amount of payments differed widely across medical specialties, for each of the 12 specialties examined the receipt of payments was associated with greater prescribing costs per patient, and greater proportion of branded medication prescribing. We cannot infer a causal relationship, but interventions aimed at those physicians receiving the most payments may present an opportunity to address prescribing costs in the US.”

The third example of such investigative study appeared in the Journal of American Medical Association (JAMA) on August 2016. This cross-sectional analysis, which included 279,669 physicians found that “physicians who received a single meal promoting the drug of interest, with a mean value of less than $20, had significantly higher rates of prescribing rosuvastatin as compared with other statins; nebivolol as compared with other β-blockers; olmesartan as compared with other angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers; and desvenlafaxine as compared with other selective serotonin and serotonin-norepinephrine reuptake inhibitors.”

This study also concluded that “Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.”

And the fourth analysis on the same subject featuring in the British Medical Journal (BMJ) of 18 August 2016 concluded that “Payments by the manufacturers of pharmaceuticals to physicians were associated with greater regional prescribing of marketed drugs among Medicare Part D beneficiaries. Payments to specialists and payments for speaker and consulting fees were predominantly associated with greater regional prescribing of marketed drugs than payments to non-specialists or payments for food and beverages, gifts, or educational materials.”

Exceptional steps by a few global CEOs – would the rest follow through?

As this juggernaut continues to move unrelenting, a few global CEOs have been taking some exceptional steps in this regard, e.g.:

- In December 2013, Sir Andrew Witty –  erstwhile global CEO of  GlaxoSmithKline tossed out the ‘Big Pharma marketing playbook’. He announced, no longer will his company pay doctors to promote its drugs or shell out bonuses to sales reps based on their ability to boost prescription numbers.

- Around September 2015, Brent Saunders – the Global CEO of Allergan was the first major drug company chief to explicitly renounce egregious price increases. Outlining his company’s “social contract with patients,” he vowed that Allergan would:

  • Limit price increases to single-digit percentages, “slightly above the current annual rate of inflation,” net of rebates and discounts
  • Limit price increases to once per year
  • Forego price increases in the run-up to patent expiration, except in the case of corresponding cost increases.

- In October 2016, Joseph Jimenez – the current global CEO of Novartis said, “We tell people, we don’t want you to deliver at any cost. We want you to deliver, but we want you to deliver in the right way,”

It’s probably a different matter, though, that one of these CEOs has already stepped down, another will do so early 2018, and third iconoclast is still in the saddle. They all are still relatively young, as compared to several of their counterparts.

These are some of the laudable steps taken by a few CEOs for their respective global operations. However, the moot question remains: would rest of the Big Pharma constituents come on board, and successfully follow these initiatives through?

That said, the overall scenario in this area, both in India and abroad, continues to remain mostly unchanged.

Why pharma does what is does?

This may not be akin to a million-dollar question, as its right answer is no-brainer – to generate more, and even more prescription demand for the respective focused brands of the concerned pharma companies. In a scenario, as we have seen above, when money can buy prescriptions with relative ease, and more money buys more prescriptions, how do the prescribers differentiate between different brands of the same molecules or combination of molecules, for greater support?

As evident from various available reports, this kind of intangible product differentiation of dubious nature, doesn’t necessarily have a linear relationship with the quantum of money spent for this purpose. Many believe, it is also intimately related to the nature or kind of various ‘gratis’ extended, some of which are highly contentious. Illustratively, how exotic is the venue of so called ‘Continuing Medical Education (CME)’ event, whether located in India or beyond its shores, bundled with the quality of comfort provided by the event managers, or even whether the spouses can also join the doctors for a few days of a relaxed trip with fabulous sight-seeing arrangements.

Regardless of many pharma players’ terming these events as purely educational in nature, lots of questions in this regard – accompanied by proof, have reportedly been raised on the floor of the Indian Parliament, as well, cutting across virtually all political party lines.

Conclusion:

Should anyone tag the term ‘marketing’ against any such pharma business practices, or even remotely accept these as integral parts of any ‘branding exercise’? For better understanding of my readers, I had explained what this buzzword – ‘branding’ really means in the marketing vocabulary.

Be that as it may, where from the pharma companies recover the huge cost of such vexed business practices? Who ultimately pays for these – and, of course, why? So far, in India, the basic reasoning for the same used to be – branded generics provide significantly better and more predictable drug quality and efficacy than non-branded generics, for patients’ safety.

This logic is anchored mainly on the argument that bioequivalence (BE) and bioavailability (BA) studies are mandatory for all generic drug approvals in India. Interestingly, that loose knot has been tightened in the draft pharma policy proposals 2017. Hope, this commendable policy intent will ultimately see the light of the day, unless another innovative new reason pops-up.

Against this backdrop, many ponder: Are the current pharma ‘marketing’ practices, especially in India, akin to riding a tiger? If the answer is affirmative, the aftermath of the new pharma policy’s coming into force – broadly in its current form and with strict enforcement measures, could well be too tough to handle for those drug players without a Plan B ready.

That said, pharma ‘marketing’ ballgame is getting increasingly more complex, with the involvement of several third-parties, as is often reported. Alongside, it’s equally challenging to fathom ‘why pharma does what it does’ to generate more prescription demand at an incremental cost, which far exceeds commensurate incremental value that branded generics provide to patients in India.

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.

Draft Pharma Policy 2017 And Branded Generics

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In its first reading, the 18-page draft Pharma Policy, 2017 gives me a sense that the Government has followed the much-desired principle of ‘walk the talk’, especially in some key areas. One such space is what Prime Minister Modi distinctly hinted on April 17, 2017, during the inauguration function of a charitable hospital in Surat. He clearly signaled that prescriptions in generic names be made a must in India, and reiterated without any ambiguity whatsoever that, to facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines.

Immediately following its wide coverage by both the national and international media, many eyebrows were raised regarding the feasibility of the intent of the Indian Prime Minister, especially by the pharma industry and its business associates, for the reasons known to many. A somewhat muted echo of the same could be sensed from some business dailies too, a few expressed through editorials, and the rest quoting the views on the likely ‘health disaster’ that may follow, if ‘branded generics’ are not prescribed by the medical profession. Obviously, the main apprehension was centered around the ‘shoddy quality parameters’ of unbranded generic drugs in India. It’s a different matter though, that none can possibly either confirm or pooh-pooh it, backed by irrefutable data with statistical significance.

Be that as it may, making high quality generic drugs accessible to most patients at affordable prices, avoiding any possible nexus between the doctors and pharma companies, which could jeopardize the patients’ economic interest, deserves general appreciation, shrill voices of some vested interests notwithstanding.  Nonetheless, if the related proposals in the new pharma policy come to fruition as such, it would be a watershed decision of the government, leaving a long-lasting impact both on the patients, as well as the industry, though in different ways, altogether.

I raised this issue in my article titled, “Is Department of Pharmaceuticals On The same Page As The Prime Minister?”, published in this blog on May 15, 2017. However, in today’s discussion, I shall focus only on how has the draft pharma policy 2017 proposed to address this issue, taking well into consideration the quality concerns expressed on unbranded generics, deftly.

Before I do that, let me give a brief perspective on ‘brand name drugs’, ‘generic drugs’, ‘branded generics’ and ‘unbranded generic drugs’. This would basically serve as a preamble to arrive at the relevance of ‘branded generic’ prescriptions, along with the genesis of safety concern about the use of un-branded generic drugs.

No definition in Indian drug laws:

Although, Drugs and Cosmetics Act of India 1940 defines a drug under section 3 (b), it does not provide any legal definition of ‘brand name drugs’, ‘generic drugs’, ‘branded generic drugs’ or ‘un-branded generics’.  Hence, a quick landscaping of the same, as follows, I reckon, will be important to understand the pertinence of the ongoing debate on ‘branded generic’ prescriptions in India, from the patients’ health and safety perspectives:

‘Brand name’ drugs:

Globally, ‘brand name drugs’ are known as those, which are covered by a product patent, and are usually innovative New Chemical Entity (NCE) or a New Molecular Entity (NME). Respective innovator pharma companies hold exclusive legal rights to manufacture and market the ‘brand name drugs’, without any competition till the patents expire.

Generic drugs:

Post patent expiry of, any pharma player, located anywhere in the world, is legally permitted, as defined in the Intellectual Property Rights (IPR) regulations, to manufacture, market and sell the generic equivalents of ‘brand name drugs’. However, it’s a global norm that the concerned generic manufacturer will require proving to the competent drug regulatory authorities where these will be marketed, that the generic versions are stable in all parameters, and bioequivalent to the respective original molecules. According to US-FDA, a ‘generic drug’ will require to be the same as the original ‘brand-name drug’ in dosage, safety, strength, quality, purity, the way it works, the way it is taken and the way it should be used.

‘Branded generic’ drugs:

Branded generics are generic molecules marketed and prescribed by their respective brand names. Around 90 percent of generic formulations are branded generics in India, involving heavy sales and marketing expenditure in various forms, which has become a contentious issue today in India. The reason being, although branded generics cost significantly more than unbranded generics, the former variety of generic drugs are most preferred by the medical profession, as a group, in India. Interestingly, there is no difference whatsoever in the marketing approval process between the ‘branded generics’ and other generic varieties without any brand names.

Unbranded generic drugs:

Unbranded generic drugs are those, which are sold only in the generic names, sans any brand name. I reiterate, once again, that there is no difference in the marketing approval process between the ‘branded generics’ and ‘unbranded generic medicines’.

The core issue:

The whole debate or concern related to both efficacy and safety on the use of unbranded generic drugs in India stems from a single regulatory issue, which is widely construed as scientifically improper, and totally avoidable. If this subject is addressed in a holistic way and implemented satisfactorily in the country, by and large, there should not be any worthwhile concern in prescribing or consuming single ingredient unbranded generic drugs in India, which generally cost much less than their branded generic equivalents.

This core issue is primarily related to establishing bioequivalence (BE) with the original molecules for all generic formulations, regardless of whether these are branded or unbranded generic drugs. Thus, positive results in bioequivalence studies, should be a fundamental requirement for the grant of marketing approval of any generics in India, as is required by the regulators of most countries, across the world.

This has been lucidly articulated also in the publication of the National Institute of Health (NIH), USA, underscoring the critical importance of generic drugs in healthcare is unquestionable. The article says: “it is imperative that the pharmaceutical quality and ‘in vivo’ performance of generic drugs be reliably assessed. Because generic drugs would be interchanged with innovator products in the market place, it must be demonstrated that the safety and efficacy of generics are comparable to the safety and efficacy of the corresponding innovator drugs. Assessment of ‘interchangeability’ between the generic and the innovator product is carried out by a study of ‘in vivo’ equivalence or ‘bioequivalence’ (BE).”

The paper further highlights, “the concept of BE has, therefore, been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe.”

Why is BE not mandatory for marketing approval of all generic drugs in India?

It is intriguing, why is this basic scientific and medical requirement of proving BE is not mandatory for granting marketing approval of all generic drugs at all time, without any exception – covering both branded generics and their unbranded equivalents, in India.

As I have already deliberated on this subject in my article titled “Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah ”, published in this blog on May 08, 2017, I shall now proceed further to relate this critical issue with the Draft Pharma Policy 2017.

Brand, branding and branded generics:

Nevertheless, before I focus on the draft pharma policy 2017, let me skim through the definitions of a ‘brand’ and the ‘branding process’, in general, for better understanding of the subject.

American Marketing Association defines a brand as: ‘A name, term, design, symbol, or any other feature that identifies one seller’s goods or services as distinct from other sellers.’ Whereas, ‘The Branding Journal’ articulates: ‘A brand provides consumers with a decision-making-shortcut when feeling indecisive about the same product from different companies.’

Business Dictionary describes the ‘branding process’ as: ‘Creating a unique name and image for a product in the consumers’ mind, mainly through advertising campaigns with a consistent theme. Branding aims to establish a significant and differentiated presence in the market that attracts and retains loyal customers.’

How does it benefit the branded generic consumers?

One thing that comes out clearly from the above definitions that brands, and for that matter the branding process is directed to the consumers. Applying the branding process for generic drugs, the moot question that surfaces is, how does it benefit the pharma consumers, significantly?

Besides, the branding process being so very expensive, adds significant cost to a generic drug, making its price exorbitant to most patients, quite disproportionate to incremental value, if any, that a branded generic offers over its unbranded equivalents. Thus, the relevance of the branding process for a generic drug, continues to remain a contentious issue for many, especially where the out of pocket expenditure for medicines is so high, as in India.

Marketing experts’ view on the branding process for drugs:

An interesting article titled ‘From Managing Pills to Managing Brands’, authored by the Unilever Chaired Professor of Marketing and a research fellow at INSEAD, published in the Harvard Business Review made the following observations on brands and the branding process for drugs:

“…It takes a huge investment to build a successful brand, consumer goods manufacturers try to make their brands last as long as possible. Some consumer products—notably, Coca-Cola, Nescafé, and Persil (a European laundry detergent) -  have stayed at the top for decades. That’s not to say the products don’t evolve, but the changes are presented as improvements and refinements rather than as breakthroughs.”

“In the pharmaceutical business, by contrast, a new product is always given a new name. Drug companies believe that only by introducing a new name can you signal to the market that the product itself is new. Unfortunately, this approach throws out the company’s previous marketing investment entirely; it has to build a new brand with each new product. That may not have mattered when pharmaceutical companies could rely on a large, high-margin market for each drug they wheeled out. But in a crowded market with tightening margins, the new-product, new-brand strategy is becoming less and less feasible.”

The above observations when applied to expensive ‘branded generics’, which are nothing but exact ‘me too’ varieties among tens other similar formulations of the same generic molecule, do not add any additional value to the patients, in a well-functioning drug regulatory environment.

Hence, to reduce the out of pocket drug cost significantly, Prime Minister Modi hinted at bringing an appropriate legal framework to address this critical issue, which gets well-reflected in the draft pharma policy 2017, as I read it.

Six key features of the draft pharma policy related to ‘branded generics’:

Following are the six key features enshrined in the draft pharma policy 2017 to translate into reality what the Prime Minister spoke about on this subject in Surat on April 17, 2017.

1. Bio-availability and Bio-equivalence tests mandatory for all drug manufacturing permissions:

For quality control of generic drugs, Bio-availability and Bio-equivalence tests (BA/BE Tests) will be made mandatory for all drug manufacturing permissions accorded by the State Drug Regulator or by the Central Drug Regulator. This will be made compulsory even for the future renewals of manufacturing licenses for all.

2. WHO GMP/GLP mandatory for all drug units:

The government shall ensure to get the World Health Organization’s Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) adopted by all manufacturing units.

3. No branded generics for single ingredient off-patent molecules:

The government will pursue the policy of sale of single ingredient drugs by their pharmacopeial name/salt name. To keep the identity of the manufacturer, the manufacturer would be allowed to stamp its name on the drug package. For patented drugs and Fixed Dose Combination (FDCs) drugs the brand names may be used.

4. ‘One company – one drug – one brand name – one price’:

The principle of ‘one company – one drug – one brand name – one price’ would be implemented for all drugs.

5. Aid and assistance to prescribe in generic names:

To aid and assist the registered medical practitioners in prescribing medicines in the generic names, e-prescription will be put into operation whereby the prescriptions will be computerized and the medicine name will be picked up from a drop-down menu of salt names.

6. UCPMP to be made mandatory:

The marketing practices of several pharmaceutical companies create an unfair advantage. To provide a level playing field, the regulation for marketing practices which is at present voluntary will be made mandatory. Penalty will be levied for violations and an agency for implementation would also be assigned.

Conclusion:

I have focused in this article only on those specific intents of the government, as captured in the draft pharma policy 2017, to reduce the out of pocket expenses on drugs for the Indian patients, which is currently one of the highest in the world. This area assumes greater importance to many, keeping in mind what Prime Minister Modi hinted at in this regard on April 17, 2017. If implemented exactly as detailed in the policy draft, this specific area would have a watershed impact both on the patients, as well as, the pharma companies, including their related business associates, lasting over a long period time.

Far reaching consequential fall outs are expected to loom large on the way pharma players’ strategic business processes generally revolve round ‘branded generics’ in India. I hope, the Plan B of many predominantly branded generic players is also receiving final touches on the drawing board by now, as this aspect of the draft policy proposal can in no way be construed as a bolt from the blue, catching the industry totally off-guard. That said, would the same changes as proposed in the draft pharma policy 2017, if and when implemented, be a ‘wow’ moment for patients?

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.