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Regulatory Failures Are Still Risking Patient Lives

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

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

Industry Response: 

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

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

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

Decades of regulatory failures persist, but at what cost? 

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

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

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

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

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

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

Only with strong accountability can India safeguard drug safety.

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

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

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

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

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

Is entity-centric accountability grossly missing in this area? 

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

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

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

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

Conclusion:

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

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

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

By: Tapan J. Ray

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

 

Ticking Some Right Boxes Biosimilar Drugs’ Acceptance Gaining Steam in India

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Looking at a broader canvas, on September 19, 2023, a credible international report flashed a headline, ‘Biosimilars making inroads into Humira sales, but docs still cautious on switching: Spherix.’ This is based on a survey of U.S. healthcare specialists, including 80 dermatologists, 83 gastroenterologists and 81 rheumatologists.

This is indeed a significant development in the realm of biologic and biosimilar drugs, internationally. If this trend gathers a strong wind on its sales, it will effectively address the need for affordable biologic drugs, especially in life threatening ailments.

According to another January 05, 2023 report, Humira, which dominated the top of the global pharmaceutical brand ranking charts between 2012 and 2022, has slipped in 2023 to no 3 in ranking as it lost its last patent protection in the US in May 2022. Doctors’ gradual acceptance of biosimilars and the price could be a key differentiator among the competitors, potentially hastening Humira’s sales decline.

On July 31, 2017, I wrote an article in this blog captioned “Improving Patient Access To Biosimilar Drugs: Two Key Barriers.” Interestingly, 6 years down the line, reflecting the same sentiment – the above September 19, 2023, report also noted that ‘efficacy remains “top of mind” as prescribers’ leading concern for adalimumab (Humira) biosimilars, followed by safety concerns and an overall lack of cost savings.’

In today’s article, I shall particularly focus on the latest developments in India and the initiatives taken by the concerned stakeholders in this area. Let me start with a quick recap of biosimilar drugs, in my understanding, so that we all are on the same page while discussing the subject.

A quick recap: 

As we know, biologic drugs are medicines made from living organisms, such as bacteria, yeast, or cells. They are used to treat a wide range of conditions, including cancer, autoimmune diseases, and infectious diseases. Biosimilar drugs are highly similar copies of original biologic drugs that have gone off patent and are typically less expensive than the original biologic drugs. However, there are still some existing barriers to doctors’ fast and wider acceptance of biosimilar drugs by many.

Current global barriers to doctors’ fast acceptance of biosimilar drugs:

  • Lack of awareness and education: Many doctors are not familiar with biosimilar drugs or the regulatory process that oversees them. This lack of awareness may lead to skepticism and hesitation about prescribing biosimilar drugs to patients.
  • Concerns about safety and efficacy: Some doctors are concerned that biosimilar drugs may not be as safe or effective as biologic drugs. These concerns are often based on a misunderstanding of the regulatory process for biosimilar drugs. 
  • Financial incentives: Some doctors may be reluctant to prescribe biosimilar drugs because they receive financial incentives from biologic drug manufacturers. These incentives can take the form of speaking fees, consulting fees, and research grants. 
  • Regulatory uncertainty: In some countries, the regulatory framework for biosimilar drugs is still evolving. This uncertainty can make it difficult for doctors to know which biosimilar drugs are safe and effective, and how to use them effectively. 

Some contemporary examples show that these barriers still exist:

As shown by the following contemporary data available to the public:

  • In 2022, a study published in the journal JAMA found that only 25% of US doctors were aware that biosimilar drugs are just as safe and effective as biologic drugs.
  • In 2023, a study published in the journal Annals of Rheumatic Diseases found that only 30% of rheumatologists in the UK were willing to prescribe biosimilar drugs to their patients. 
  • In 2023, a study published in the journal Cancer found that oncologists in the US were more likely to prescribe biologic drugs to their patients if they had received financial incentives from biologic drug manufacturers. 
  • In 2023, a report published by the European Commission found that the regulatory framework for biosimilar drugs in the EU is still complex and fragmented.

Measures being taken to address these barriers, globally?

There are a number of things that can be done to address the barriers to doctors’ fast acceptance of biosimilar drugs. These include:

  • Education and outreach: More needs to be done to educate doctors about biosimilar drugs and the regulatory process that oversees them. This education should come from a variety of sources, including medical schools, professional organizations, and pharmaceutical companies.
  • Financial transparency: Pharmaceutical companies should be required to disclose all financial payments they make to doctors. This transparency will help to reduce the potential for conflicts of interest.
  • Regulatory harmonization: The EU should work to harmonize the regulatory framework for biosimilar drugs across member states. This will make it easier for doctors to prescribe biosimilar drugs to their patients.

By addressing these barriers, it is possible to increase the acceptance of biosimilar drugs and make them more accessible to patients. This will lead to lower healthcare costs and improved patient outcomes.

Indian scenario of biosimilar drugs, issues and actions:

As reported, India is a global leader in the production and development of biosimilar drugs. The Indian biosimilar market is expected to reach $30 billion by 2025. Biosimilar drugs in India are typically 30-70% cheaper than original biologic drugs. For example, a vial of the biologic drug Herceptin costs around INR 1 lakh, while a vial of the biosimilar drug Trastuzumab costs around INR 30,000.

The key reasons for price arbitrage:

The price difference between biosimilar drugs and original biologic drugs is due to a number of factors, including:

  • Lower development costs: Biosimilar drugs are less expensive to develop than original biologic drugs because they do not require the same level of research and clinical trials. 
  • Increased competition: There is more competition among biosimilar manufacturers, which drives down prices. 
  • Government support: The Indian government provides financial incentives to biosimilar manufacturers, which also helps to keep prices low. 

Biologic drugs, especially biosimilar insulin, some medications for cancer and a variety of autoimmune diseases, have been proved to be very effective for patients. That said, original biologic drugs can also be very expensive. Biosimilar drugs are making these drugs more affordable for patients.

Indian stakeholder initiatives and support is essential:

Indian key stakeholders are also supportive of the biosimilar industry and have taken a number of steps to promote its growth. Some of the recent ones are: 

  • In 2022, the Indian government announced a new policy that will give preference to biosimilar drugs in government procurement. This policy is expected to save the government billions of dollars in healthcare costs.
  • In 2023, the Indian government launched a new awareness campaign to promote the use of biosimilar drugs. The campaign is targeting doctors, patients, and healthcare policymakers.
  • In 2023, a number of leading private hospitals in India announced that they would be switching to biosimilar drugs for a range of conditions. These hospitals include Apollo Hospitals, Fortis Healthcare, and Max Healthcare.
  • In 2023, the Indian Pharmaceutical Alliance (IPA) released a report that found that the use of biosimilar drugs in India had increased by 20% in the past year. The report also found that the use of biosimilar drugs was expected to continue to grow in the coming years.

These are just a few examples of the growing acceptance of biosimilar drugs in India. As more and more doctors and patients become aware of the benefits of biosimilar drugs, we can expect to see their use continue to grow in the coming years.

State-specific advantages for greater acceptance of biosimilar drugs in India: 

As available from different reports, the following are some specific examples of state-specific advantages that have led to the greater acceptance of biosimilar drugs in India:

  • In 2022, the government of Maharashtra launched a scheme to provide financial incentives to doctors who prescribe biosimilar drugs. Under the scheme, doctors who prescribe biosimilar drugs to at least 20% of their patients are eligible to receive a bonus of up to INR 10,000 per month.
  • In 2023, the government of Gujarat launched a campaign called “Biosimilar Drugs: Safe, Effective, and Affordable.” The campaign aims to educate doctors and patients about the benefits of biosimilar drugs and to dispel any myths or misconceptions about them. 
  • The states of Karnataka and Telangana have a number of leading biopharmaceutical companies that are developing and manufacturing biosimilar drugs. These companies are working with doctors and hospitals in these states to promote the use of biosimilar drugs. 

As a result of these advantages, the acceptance of biosimilar drugs is growing rapidly in some states in India. For example, in Maharashtra, the use of biosimilar drugs increased by 25% in the past year.

Conclusion:

Against the above backdrop, I reckon, the acceptance of biosimilar drugs is gaining steam in India now. This is due to a number of factors, including rising costs of original biologic drugs, government support, growing availability of biosimilar drugs, and increasing awareness and education.

It is important to note that biosimilar drugs are just as safe and effective as original biologic drugs, but they are much more affordable. This is making it possible for more patients to access the treatment they need, especially for life-threatening ailments. 

By: Tapan J. Ray

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

 

India’s Drug Quality Concerns: Is Light At The End of The Tunnel In Sight Now?

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A brief chronology of some recent events on issues pertaining to patient-health-safety with drugs, as captured below, would possibly generate a mixed feeling for many. This includes a serious concern about, especially generic drug quality safety standards in India, on the one hand, and a ray of hope in the tools available to patients to know more about drugs that they have been prescribed. In this article, I shall dwell on this area. My intent is to bring to the fore the vital point – Is the beginning of the end of a long dark tunnel in sight now?

 A chronology of some recent events:

As reported on July 16, 2023, while talking on the subject, “Pharmaceutical Quality — What are we missing?”, the Drug Controller General of India (DCGI) made a notable comment. He, reportedly, said that the poor quality of drugs exported from India to foreign countries had tarnished the image of the country in the international market. The DCGI further added, pharmaceutical quality has become a subject of discussion on the global platform and the international community has started doubting whether India is capable of making quality pharmaceuticals for the global population.

He underscored, “We boast of our country as the pharmacy of the world, but it seems that it is too difficult to maintain the top position for long. If the position is lost, it will be painful and difficult to restore the faith of the international community. Further, we will lose the opportunity to serve the whole humanity of the world. The responsibility of the loss will not only fall on the manufacturers, but equally on all the stakeholders.”

Alongside, a news report on August 01, 2023, brings some hope in this regard, which I shall elaborate in course of this deliberation.  

A long saga of events: 

Yes, as it appears from the following backdrop:

Over the last several decades, there have been many instances where international drug regulators, including the U.S. FDA, expressed concerns about the quality standards of Indian manufactured drugs. These concerns have generally been related to specific manufacturing facilities – ranging from top domestic manufacturers to smaller ones, raising an uncomfortable apprehension – does India produce ’World-Class’ medicines, for all? 

About a decade ago, one of the most well-known cases was in 2013 when the U.S. FDA issued an import alert on products from the Ranbaxy Laboratories facility in India due to data integrity and manufacturing quality issues. This led to significant scrutiny of other Indian pharmaceutical companies as well. Issues related to data integrity, product quality, and good manufacturing practices lead to inspections, warning letters, import alerts, or other regulatory measures.

It continued. For example, around that time, even Sun Pharmaceutical Industries, one of India’s largest pharmaceutical companies, received a warning letter from the U.S. FDA in 2015 (Source: U.S. FDA). Similarly, Wockhardt, another top Indian pharmaceutical company, faced regulatory scrutiny in 2013 when the U.S. FDA issued an import alert and seized products manufactured at their facility in India. The FDA raised concerns about violations of good manufacturing practices and data integrity issues at the facility. This led to recalls of several products and affected the company’s reputation. (Source: Reuters).

As the juggernaut kept moving, on  December 08, 2016, I wrote in this blog, “Even Smaller Countries Now Question Indian Drug Quality Standard.” On March 04, 2023, the Mint reported, “Death of children in Gambia linked to consumption of India made cough syrups, as the US CDC report states.”  

As I write, the veracity of impact of such incidences remains as serious, if not more, although instances seem to be much fewer. For instance, as reported by Reuters on August 01, 2023: “India has directed Riemann Labs, a manufacturer linked to cough syrup deaths in Cameroon, to stop manufacturing activities, the country’s health ministry said in a statement on Tuesday.”

Thus, On May 27, 2019, I again wrote about: “Drug Quality Imbroglio And ‘Culture of Bending Rules’ in India” in this blog– and that was not the first time I flagged this menace in the country against patient safety.

Even big Indian pharma continued to be struggling with GMP issues:

Big Indian pharma companies are also involved in issues related to lapses in high drug quality standards even recently. Such as, even in 2021, Dr. Reddy’s Laboratories, received a warning letter from the U.S. FDA after an inspection of their manufacturing facility in India. The letter cited violations of good manufacturing practices, data integrity issues, and inadequate investigations of product complaints. Source: The Economic Times). Just a year before, in 2020, the U.S. FDA noted several observations related to good manufacturing practices and quality control. (Source: Moneycontrol).

Drug regulators fight the fire as and when it comes up:

Both the state drug regulators and the Drug Controller General of India (DCGI) fight the fire at the respective manufacturing locations, as and when these come up. No significant actions on the ground for patient safety against such drugs were visible on the ground.  

For example, as reported on August 03, 2023: “Following recent incidents of several countries reporting deaths allegedly linked to “contaminated” India-manufactured drugs, the government has set a deadline for mandatory implementation of the Good Manufacturing Practices (GMP) which were revised in 2018, bringing them on par with World Health Organization (WHO) standards.”

The government ponders making technological interventions for patients:

There are early signs of the government trying to embrace technology for patients’ safety. For example on November 17, 2022, the Union Health Ministry released a gazette notification no 823Eimplementing the Drugs (Eighth Amendment) Rules, 2022, making it mandatory for pharmaceutical companies to affix a QR code on the pack of top 300 formulations from August 1, 2023. A QR code, as reported, will contain the unique product identification code, generic name of the drug, brand name, name and address of the manufacturer, batch number, date of manufacture, expiry date and manufacturing license number.

This was part of the Ministry’s ‘track and trace’ mechanism, and of course, an intent at that time. However, a specific timeline for implantation has now been clearly enunciated.

This time it’s a two-pronged action:

For the first time, I think, a two-pronged action has been announced by the government – an enabling action for patients on the one hand against a strong punitive measure for the errant drug manufacturers on the other:

According to the above gazette notification of the Union Ministry of Health, on August 01, 2023, the central government announced stricter regulations for drug authentication and transparency by imposing mandatory QR codes on drugs. This will be effective from the same day. Patients will now be able to check the QR code on their medicines to ensure their authenticity. 

On August 03, 2023, the government set a deadline for adopting WHO-standard good manufacturing practices for drug manufacturers. Companies with a turnover of over Rs 250 crore will have to implement the revised GMP within six months, while medium and small-scale enterprises with turnover of less than Rs 250 crore will have to implement it within a year. 

Conclusion:

Besides all important patient safety, there are, at least, three other important factors for manufacturing high quality drugs for all and on an ongoing basis, sans lapses, as below:

  • Patients’ trust in the healthcare system relies on the availability of reliable medication. When patients have confidence in the drugs they are prescribed, they are more likely to comply with treatment regimens, leading to better health outcomes. 
  • A strong pharmaceutical sector that focuses on safe and effective drugs can foster economic growth by generating revenue, creating jobs, and attracting investments. It can also stimulate research and development efforts.
  • A reputation for producing quality drugs can boost India’s position as a global leader in pharmaceuticals, attracting international collaborations and partnerships.

Which is why, from the entire perspective, as above, amid India’s drug quality concerns, I reckon, one may still tend to wonder now – Is a light in sight now at the end of the dark and long tunnel? 

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.

 

To Reduce Disease Burden India Launches A New Study On Access to Affordable Drugs

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As India is struggling hard to come out of economic meltdown, and more – while navigating through the Covid-19 pandemic, the issue of reducing the National Disease Burden (NDP) with comprehensive measures resurfaces. According to a World Bank study, with ’17.5% of the global population, India bears 20% of the global disease burden.’

It’s also a well-reported fact that one such critical measure in this area is expanding access to affordable medicines to a vast Indian population. This is essential, despite some laudable measures taken by the country in this space. Which is why, it has attracted the government’s focus – yet again, even in the new normal.

This is evident from the Notification of the Department of Pharmaceuticals (DoP) dated 13.01.2022. This pertains to the DoP’s request for Proposal (RFP) from reputed companies, “To study the drug pricing policies of different countries/ region and lessons learnt from these countries/ regions in terms of access to medicine at affordable prices.” The selected company will conduct the study, on behalf of the government to understand the drug pricing methodology adopted in at least 10 countries, it said.

According to the RFP document, a minimum of ten countries/regions that should be covered are – Sri Lanka, Bangladesh, China, EU, UK, Australia, USA, Brazil, South Africa, and Thailand. It also mentioned, after selection – the chosen company has to submit its final report in four months, besides quarterly progress report during this period.

This article will focus on the relevance of a renewed government focus on access to affordable medicines, after the third wave of the pandemic, even after various recent measures undertaken by the government in this direction.

What does ‘access’ mean in the healthcare context – a recap:

Although, ‘access’ is a well-used word in the health care scenario, let me recapitulate the same to be on the same page with my readers in this discourse. According to the Agency for Healthcare Research and Quality (AHRQ): Access to health care means having “the timely use of personal health services to achieve the best health outcomes.” It has four components, namely:

  • Coverage: facilitates entry into the health care system. Uninsured people are less likely to receive medical care and more likely to have poor health status.
  • Services: provides a source of care, associated with adults receiving recommended screening and prevention services.
  • Timeliness: ability to provide health care when the need is recognized.
  • Workforce: capable, qualified, culturally competent health care personnel.

Let me emphasize again that the purpose of recapitulating what does healthcare ‘access’ mean, is to give a sense of how are we positioned in India, in this regard.

Key reasons for inadequate access to healthcare, especially in India:

Following are three fundamental reasons for lack, or inadequate access to healthcare, as relevant to India:

  • A large section of the population cannot access healthcare owing its cost relative to their respective income.
  • Many others can’t access, as no quality and affordable facilities are located nearby where they live.
  • Most importantly, a large Indian population can’t have adequate access to quality health care, because they don’t have any healthcare coverage. This point was flagged by the AHRQ, as well.

It is, therefore, noteworthy that to ensure access to quality healthcare, either free or affordable, health coverage for all – public or private, is critical for any nation. Whereas a large Indian population still remains without any health coverage, as the recent government publications vindicate.

Despite high OOPE a large population is still without any health coverage:

On this issue, NITI Aayog report, published in October 2021, shared some important facts. A staggering number of over 400 million Indians, still live without any financial protection for health. This is despite the launch of ‘Ayushman Bharat – Pradhan Mantri Jan Arogya Yojana (AB-PMJAY)’ launched in September 2018, and State Government extension schemes, the paper says. Notably, ‘the actual uncovered population is higher due to existing coverage gaps in PMJAY and overlap between schemes,’ the report added.

Interestingly, the paper acknowledged: “Low Government expenditure on health has constrained the capacity and quality of healthcare services in the public sector. It diverts most individuals – about two-thirds – to seek treatment in the costlier private sector. “As low financial protection leads to high out-of-pocket expenditure (OOPE). India’s population is vulnerable to catastrophic spending, and impoverishment from expensive trips to hospitals and other health facilities,” it observed.

The government spending on public health at 1.5% of GDP, remains among the lowest in the world impacting reach, capacity, and quality of public healthcare services. It is compelling people to seek treatment in the costlier private sector. Almost 60% of all hospitalizations, and 70% of outpatient services are delivered by the high-cost private sector, NITI Aayog highlighted.

Major part of OOPE goes for buying drugs:

According to the W.H.O’s health financing profile 2017, 67.78% of total expenditure on health in India was paid out of pocket, while the world average is just 18.2%. Moreover, the Union Health ministry had also reported that ‘medicines are the biggest financial burden on Indian households.’ Around 43% of OOPE towards health, reportedly, went for buying medicines and 28% in private hospitals.

Thus: ‘Much of this problem of debt can be solved if medicines are made available to people at affordable prices. The National Health Policy 2017 also highlighted the need for providing free medicines in public health facilities by stepping up funding and improving drug procurement and supply chain mechanisms,” the report added.

Access to affordable drugs continues to remain a top priority today:

The above point was also emphasized in the Annual Report 2020-21 of the Department of Pharmaceuticals. It underscored: ‘The Government is now contemplating to introduce a new National Pharmaceutical Policy, where – ‘Making essential drugs accessible at affordable prices to the common masses,’ featured at the top of the policy objectives, as follows:

  • Making essential drugs accessible at affordable prices to the common masses.
  • Providing a long-term stable policy environment for the pharmaceutical sector.
  • Making India sufficiently self-reliant in end-to-end indigenous drug manufacturing.
  • Ensuring world class quality of drugs for domestic consumption & exports.
  • Creating an environment for R & D to produce innovator drugs;
    Ensuring the growth and development of the Indian Pharma Industry.

What happens when all will come under health coverage, if at all:

Even when, and if, all Indians comes under health coverage – public or private – drug cost will continue to play a major role even to the institutional payers. This is mostly to ensure the cost of health coverage remains reasonable, and affordable to all. This can possibly be done either through:

  • Price negotiation with the manufacturers, or
  • Price control by the government

In any case, there needs to be a transparent mechanism for either of above two, which the government seems to be refocusing on, as it appears today.

Conclusion:

Thus, to reduce the burden of disease in India, especially after going through a harrowing experience of the Covid-19 pandemic, where co-morbidity posed a major threat to life, India is likely to up the ante, as we move into the new normal.

From this viewpoint, a brand-new study, as mentioned above, initiated by the government to facilitate expanded access to affordable medicines, is a laudable initiative for all Indians. It’s a noteworthy point for the drug industry, as well, especially, the research-based pharma and biotech companies. As I wrote before, they should also pick this signal to focus on all 3 areas of innovation for affordable access to innovative drugs, not just on costly patented drugs for only those who can afford.

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.

 

 

Create Novel Marketing Pathways As Covid Mutants Keep Emerging

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The World’s battle against wave after wave unsettling onslaught of Coronavirus on human lives and livelihood continues, since December 2019. The first wave was triggered by the novel Covid-19 from Wuhan in China, the second by its deadly – Delta variant, and now – the third by Omicron. In India, first case of Covid-19 was reported on January 31, 2020.

Initially, global experts contemplated vaccines to prevent and contain Covid-19 and were the best hope for ending the pandemic. However, the effectiveness of existing Covid vaccines apparently declines against its subsequent mutants. This is evident even in India when the next variant Omicron commenced its onslaught.

The good news is, AstraZeneca has now claimed, a third booster shot of its Covid-19 vaccine willsignificantly boost antibody levels against the Omicron variant. However, Omicron may not be the last Covid-19 variant, as it appears today.

As the world grapples with the highly mutated Omicron, scientists have identified another new strain of the COVID-19 causing virus – in Southern France – known as ‘IHU’. This B.1.640.2 variant was reported by researchers at institute IHU Mediterranee Infection in at least 12 cases. However, it is too early to speculate on how this variant behaves as far as infection and protection from vaccines is concerned. This process is likely to take, at least, some more time.

Thus, in the current situation, when increasing numbers of even fully vaccinated individuals are getting re-infected caused by emerging mutants of Covid-19, and some more than once, the focus expanded towards more effective disease treatment. Some countries, such as the US, have decided for the 3rd booster shot of Covid-19 vaccine. Israel has even gone for the 4th booster shot of Covid vaccine. Be that as it may, in this fast-evolving scenario, even bright pharma marketers have been experiencing new strategic challenges, as we move on. Against the above backdrop, this article will delve into that space, focusing on some of the new trends of the new normal.

Pharma’s focus expands towards more effective Covid specific treatment:

Visualizing the way Covid-19 pandemic could possibly pan out in the foreseeable future, several global pharma and biotech companies have started focusing on specific treatment for this virus, ensuring speedy patient recovery.

For example, on November 21, 2020, the U.S. FDA issued an emergency use authorization (EUA) for a cocktail therapy of casirivimab and imdevimab for the treatment of mild to moderate COVID-19 in adults and pediatric patients.

Just a month later, on December 22, 2021, the U.S. FDA issued another emergency use authorization (EUA) for Pfizer’s (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use). This was also for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults and pediatric patients.

A day after Pfizer’s the first oral COVID-19 treatment, approval, on December 23, 2022, the U.S. FDA issued one more emergency use authorization (EUA) for Merck’s molnupiravir. This is the second antiviral pill authorized in the U.S, for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults. Nearer home, the Drug Controller General of India (DCGI) has also given EUA to Molnupiravir for the treatment of adult patients.

Interestingly, French regulators rejected Merck’s molnupiravir pill for low efficacy. They found other therapies were much more effective than this molecule. Even in India on January 06, 2022, the Indian Council of Medical Research (ICMR) also expressed safety concerns on Molnupiravir. Thus, it has not been included in the national list of Covid treatments in India. That said, such brilliant initiatives by several pharma companies in the battle for saving lives and livelihoods against Covid-19 pandemic, made those companies household names like never before.

Covid made several pharma companies household names, but not brands:

This point was restated in a recent article, published in the Fierce Pharma on December 22, 2021. It emphasized, Covid-19 ‘has brought the words of the pharma industry into people’s lives like never before: Moderna, Pfizer, BioNTech, AstraZeneca and Merck have become household names.’ One may not remember the names of their Covid products, but will mostly know the company.

Many people have now started referring to Covid vaccines and drugs in generic names. As from the very beginning we started hearing people saying, like – I got ‘AstraZeneca Vaccines’, ‘Remdesivir’, or ‘Covid Cocktail therapy’. Company names usually followed the generic names in most cases. Although, ‘that’s been good for pharma’s reputation, but has left marketers in a bind about branding, commented the above article.

Most Covid-19 drugs and vaccine brands are on ‘emergency use approval’

In the Covid dominated year of 2021, drug and biotech companies managed to get USFDA approval for 55 new drugs. However, many of those drugs and vaccines got only Emergency Use Approval (EUA) and only under emergency use basis. This basically means, under EUA these companies did not get full marketing approval and were handicapped to go whole hog with the usual new brand marketing campaigns.  This critical issue is expected to remain even in 2022.

In a situation, such as this, when the full scale branding initiatives can’t be undertaken, intenseCorporate Branding Campaigns, I reckon, would pay a rich dividend. This process will be quite different from creative new brand marketing in the old normal. Some global innovator companies are using even the mass media to promote their respective vaccines, albeit differently.

Such promotions include, Open Letter from the Company CEO, creative use of TV shows, messages of the head honchos through twitter or word of mouth campaigns – creating a snowballing effect. Alongside, healthcare marketing professionals are also intensifying their Covid-vaccine ad campaigns, sans brand names, to increase awareness and persuade more people to get vaccinated, soon.

To move in this direction, at least, during EUA period for Covid drugs and vaccines, hybridization of pharma marketing will be necessary in many cases, which won’t be an easy task for all, though.

Hybridization of pharma marketing – necessary – but not an easy task:

Based on experience of almost the last two years, many drug companies have realized that virtual-only customer engagement models have some serious shortcomings to fetch desired outcomes. This issue was studied and well-articulated in an article, published in the Reuters Events on November 30, 2021.

It found: “Virtual-only engagement can make it harder to create a real connection.” Further, as the paper articulated: “Even if HCPs share their video, we are losing the third dimension, hence losing out on parts of that personal component.’ Besides, although, online meetings are flexible regarding timing, if a doctor doesn’t dial-in, there is only a small chance the meeting will happen later that day, unlike waiting in a clinic for the interview to take place.

To address this issue, pharma players are now in various stages of creation and adoption of their respective hybrid marketing models. However, the process offers its own challenges. Working out customer-specific hybrid engagement models are a different ball game altogether- requiring very different skill sets, continuous training and above all a very different mindset.

Conclusion:

As reported on January 06, 2022, rapidly spreading Omicron variant of the novel Coronavirus threatens to rewrite the business recovery timelines, even in India. Even recently, many CEOs and top executives have opined, businesses would have to live with Covid-19 uncertainty. The article further added: ‘Many companies have suspended their return-to-work plans and are reassessing business continuity measures as a third wave of the pandemic starts to surge.’ Most CEOs also expressed one of their top priorities was to ensure Covid-19 protocols were being followed and all employees were safe.

Similar situation arises for all Covid drugs approved under the EUA by the Drug Controller general of India, and are being marketed by Indian companies against non-exclusive voluntary licensing agreements with the innovators. Thus, an analogous marketing issue exists surrounding all such EUAs, as the company concerned can’t undertake a full brand marketing campaign. This constraint is likely to pose a major marketing challenge for several potential Covid blockbuster drugs in India, at least in 2022, which marketers need to overcome, creatively.

From the above perspective of Covid-19 drugs and vaccines, companies would need to create novel and effective strategic pathways for performance excellence. At least, as long as Covid-19 mutants will continue to emerge, causing operational disruptions in the pharma business.

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.

 

Focus On All 3 Areas of Innovation For Affordable Access To Innovative Drugs

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Medical treatment has made astonishing advances over the years. But the packaging and delivery of that treatment are often inefficient, ineffective, and consumer unfriendly. This was articulated in an article on innovation in healthcare, published in the Harvard Business Review, way back, in its May 2006 issue.

Highlighting soaring healthcare cost, including ‘out of pocket’ health expenditure, and its impact on public health, the paper recommended innovative solutions for every related aspect of health care. These encompass – healthcare delivery, unleashing the power of technology, and customer-centric business models. Interestingly, despite enormous investment in drug innovation, the access to affordable health care for all, continued over the years.

The consequential scenario was well articulated in another paper on rising consumerism among healthcare consumers, published in the Deloitte Review issue 16, 2015. It noted, the existing business models are increasingly being challenged by all concerned. The aim is to find new sources of value – as expected by patients and deliver them effectively with innovative approaches for better outcomes. This has, initiated a recalibration of the healthcare system, as it were, in many parts of the world, including many -both developed and developing countries, across the globe.

In this article, I shall try to explore this area, especially from the perspective of relevance of innovative business models for affordable access to innovative drugs in the new normal. Let me start with three basic innovation needs in the pharma business that may help chart out a meaningful pathway to attain this goal.

3 innovation areas to make health care better and cheaper:

In pharma industry, people mostly talk about product or treatment innovation. Although, this is of paramount importance to make healthcare more and more effective with time, but may not help save or heal more patients, commensurately.

Going by the ‘health care innovation catalog,’ as charted by the above Harvard Business Reviewarticle, ‘three kinds of innovation can make health care better and cheaper.’ These innovations are primarily related to:

  • Use of ‘technology’ to develop new products and treatments or to improve care
  • Bringing in innovative changes the ways ‘consumers’ buy and use healthcare.
  • Generating new ‘business models’, particularly those that involve the horizontal or vertical integration of separate health care organizations or activities.

As I have deliberated in the past, related to the first two areas, this discourse will deliberate on the third type of innovation to explore the above specified area. Let me hasten to add that several studies published in the later dates, echoed similar approach.

Subsequent studies reinforce the point:

One such example, is the paper titled ‘Innovative Approaches to Increase Access to Medicines in Developing Countries’, published in the Frontiers in Medicine on December 07, 2017. This study also captured: ‘Access to essential medicines is problematic for one third of all persons worldwide. The price of many medicines (i.e., drugs, vaccines, and diagnostics) is unaffordable to the majority of the population in need, especially in least-developed countries, but also increasingly in middle-income countries.’

The paper highlighted, several innovative approaches, based on partnerships, intellectual property, and pricing, can further stimulate innovation, promote healthcare delivery, and reduce global health disparities, significantly. It underscored: ‘No single approach suffices, and therefore stakeholders need to further engage in partnerships promoting knowledge and technology transfer in assuring essential medicines to be manufactured, authorized, and distributed in low- and middle-income countries (LMICs) in an effort of making them available at affordable and acceptable conditions.’

Changing business model concept gaining steam during Covid pandemic:

The issue of affordable access to innovative medicines drew attention of all stakeholders, even the common man, during the Covid pandemic – more than ever before. Several publications raised a flag on this barrier to public health, especially amid a pandemic or epidemic like situation.

One of these papers, titled ‘COVID-19 and the global public health: Tiered pricing of pharmaceutical drugs as a price-reducing policy tool’, was published in the Journal of Generic Medicines, on October 07, 2020. The paper emphasized, COVID-19 has raised serious concerns about affordable and equitable access to critically needed innovative medicines and other health technologies. It pointed out: ‘Patent exclusivities add to the cost of healthcare by allowing supra-competitive prices of protected technologies’, it commented. At the same time, ‘the prices and availability of drugs also depend on certain other factors that are not related to IP protection.’

Here comes the concept of ‘differential pricing’ or ‘tiered pricing’. This is a voluntary price-reducing policy option of the innovator to sell innovative drugs at lower prices in developing countries – compared to developed nations. The study articulated, more and more innovators imbibing this option in the future, could be a way forward to address for the future. Could it be a win-win solution for this critical issue?

Is it a win-win solution to this critical issue?

Since, at least, the last decade, the concept of differential pricing or tiered pricing ‘has received widespread support from industry, policymakers, civil society, and academics as a way to improve access to these life-saving products.’ This was also noted in the paper - ‘A critical analysis of tiered pricing to improve access to medicines in developing countries,’ published in the journal Globalization and Health, on October 12, 2011.

Even at that time, the paper said: ‘International tiered pricing has been proposed as an alternative to high prices when separable high- and low-to-middle-income markets exist for a medicine and when the seller exerts significant power over pricing, such as when there is limited or no competition due to patent protection, data exclusivity, or other market-entry barriers.’

Interestingly, despite above findings, tiered pricing has not been a widely followed concept in the old normal to ensure affordable access to life-saving innovative drugs, for all. One of its reasons could possibly be commercial considerations. Company specific business threshold of tiered pricing may not necessarily be able to offer a price that is equitable or affordable for all. That said, there are a few laudable initiatives of some major innovator companies in the past.

Some laudable past initiatives for affordable access to innovative drugs:

Since the beginning of this millennium, one can witness some laudable pricing initiatives for affordable access to critical, innovative drugs to save lives in developing countries and poorer nations. Let me give a few reported examples below:

  • Abbott Laboratories – the patent holder of lopinavir and ritonavir had initially announced a tiered price of $650 in 2001 for African countries and 16 non-African least developed countries. In 2002, the Company reduced the price to $500 for these countries and in August 2009 dropped it to $440 – slightly below the lowest generic price.
  • In 2001, Novartis offered “at-cost” tiered price of $2.40 per adult treatment course for artemether-lumefantrine FDC to WHO for developing countries After 5 years when a generic version of the same was available, Novartis decreased its tiered price to $1.80, thereafter to $1.50.
  • Eli Lilly’s two key DR-TB drugs, capreomycin and cycloserine were not widely available from other suppliers even after it went off patent. In 2002, Lilly transferred the drug manufacturing technology to several generic drug companies in TB-endemic countries. Eli Lilly’s tiered price has consistently remained below the generic prices for these drugs.

More examples of voluntary licensing during Covid pandemic:

Gilead signed non-exclusive voluntary licensing agreements with generic pharmaceutical manufacturers based in Egypt, India and Pakistan to manufacture remdesivir for distribution in 127 countries that face significant obstacles to healthcare access.

Notably, the licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent COVID-19, whichever is earlier.

On May 11, 2021, several media reports revealed that ‘US pharma giant Eli Lilly has issued royalty-free, non-exclusive voluntary licenses to three Indian drug makers – Cipla, Sun Pharmaceuticals and Lupin – to manufacture and distribute Baricitinib, which is being used to treat Covid-19.

As announced on October 27, 2021, the global drug major MSD and Medicines Patent Pool (MPP) entered into a voluntary licensing agreement to facilitate affordable global access for molnupiravir, an investigational oral COVID-19 antiviral medicine. This agreement will help create broad access for molnupiravir use in 105 low- and middle-income countries (LMICs) including India following appropriate regulatory approvals. The Indian companies, reportedly, include, Sun Pharma, Cipla, Dr Reddy’s, Emcure Pharma and Hetero Labs.

On November 16, 2021, Pfizer Press Release stated: Pfizer and MPP has signed a voluntary license agreement for Pfizer’s COVID-19 oral antiviral treatment candidate PF-07321332, which is administered in combination with low dose ritonavir (PF-07321332; ritonavir). Under the terms of the license agreement, qualified generic medicine manufacturers worldwide that are granted sub-licenses, will be able to supply this combination drug to 95 countries, covering up to approximately 53% of the world’s population.

Conclusion:

Covid Pandemic, which apparently, is refusing to vanish anytime soon, makes the issue of making affordable access to critical innovative drugs for all, more intense. Since long, researchers, academicians, practitioners, and the stakeholders involved in addressing this healthcare challenge for the majority of the population have suggested several innovative approaches.

These include, focus on three kinds of innovation simultaneously, and with similar zest, can make health care better and cheaper. One such area is changing pharma business models for critical innovative drugs. The good news is a few pharma players have already charted on this pathway in the past, successfully, by extending royalty-free, voluntary licenses to manufacturers in the developing countries and poorer nations. Some of them even tried to match their tiered pricing with equivalent generic drug prices. But the overall response was rather lukewarm in the old normal. Interestingly, the new normal signals a mindset change in this regard within a larger number of global innovators.

The current trend gives a hope to many that an increasing number of global innovators will sincerely explore – not just one, but all the three areas of innovation for affordable access to innovative drugs. This could possibly reduce, if not eliminate the future need for the grant of compulsory licenses for such drugs, as happened during the peak of Covid pandemic, especially 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.

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

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

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

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

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

What ‘interchangeability’ really means:

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

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

Overcoming a tough barrier to biosimilar market growth:

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

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

Are interchangeable biosimilars superior to other biosimilars?

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

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

Expanding biosimilar market:

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

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

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

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

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

Conclusion:

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

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

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

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

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

By: Tapan J. Ray   

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

What Have And Haven’t Changed In Pharma’s New Normal?

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While navigating through the challenge of disruptive changes, several pharma marketers are now focusing more on creating, connecting, and leveraging all market and customer related data, across the organization. Astute ones are using state-of-the-art tools, platforms, and techniques to gain actionable insights on new demands of pharma markets. I wrote about it in my article - ‘Data: the new ‘Magic Wand’ For Pharma Business Excellence,’ published in this blog on October 01, 2018.

This process is helping them to fathom what areas the pandemic has changed and what it hasn’t. Their aim is to draw cutting-edge strategies accordingly for market effectiveness – outperforming competition. This article will explore that space with contemporary examples. Let me start with a few illustrations of some hits and misses for the treatment of Covid – as the world started learning to live with this menacing virus. This was enviable, as the requisite scientific date wasn’t readily available at that moment of truth. But the time has changed now.

Some hits and misses:

As the pandemic overwhelmed the world, and no well-documented treatment for infection caused by the brand new virus – Covid-19 was available, many drug players were given quick emergency approval by country regulators for some repurposed drugs. But most of those weren’t found effective as fresh clinical data started pouring in. For example, the World Health Organization (WHO), have, reportedly, indicated that remdesivir, hydroxychloroquine, lopinavir/ritonavir and interferon regimens appeared to have little or no effect on 28-day mortality or the in-hospital course of COVID-19 among hospitalized patients.

More recently, Gilead Sciences Veklury – a failed Ebola drug, repurposed for hospitalized Covid-19 patients, suddenly became a blockbuster drug, according to a September 17, 2021 report. However, in less than a year, alongside more research data - a study from Europe, published in The Lancet Infectious Diseases, showed that Veklury has no real benefit. The report also highlights: ‘Aided by a ringing endorsement from then-president Donald Trump, Veklury rang up sales of $2.8 billion in 2020, including $1.9 billion in the final quarter. But those sales slid this year to $1.5 billion in the first quarter followed by $829 million in the second quarter.’

Similarly, there are several areas that are seemingly getting transformed, triggered by the pandemic and the time for resorting to a hit or miss approach, is now virtually over. From pharma marketers’ point of interest, it will now be at one’s own peril for not challenging the pre-Covid business traditions, rules, and well-tried strategies on customer relationships and brand building models. This brings us to the question on what specifically have changed in the new normal as the pharma industry navigates thorough the Covid pandemic – for close to two years now.  

Pandemic-triggered changes in the pharma marketing area:

Changes are many and are being studied across the world. One such recent analysis, articulating how the pandemic triggered changes have redefined marketing, was published by the Harvard Business Review (HBR), on March 10, 2021. This paper came more than a year after the pandemic overwhelmed the world. This article listed some interesting macro-level changes, including the following:

  • Old normal: You are competing with your competitors.
  • New normal: You are competing with the last best experience your customer had.
  • Old normal: Customers hope you have what they want.
  • New normall: Customers expect you to have exactly what they want.
  • Old normal: Courting customers is just like dating.
  • New normal: Courting customers is just like online dating.
  • Old normal: Customers must sit at the heart of your marketing strategy.
  • New normal: Customers must sit at the heart of your customer journey.
  • Old normal: Agility is a technology process.
  • New normal: Agility is a modern marketing approach.
  • Old normal: Your brand should stand behind great products.
  • New normal: Your brand should stand behind great values.

To illustrate the point, let me now give a few examples of some micro-level changes in the same space.

Some transformation trends:

I am citing a few examples related to pharma’s traditional sales and marketing models. One such area is, quite a few companies are adopting connected data based and analytics-supported Omnichannel approach for customer engagement. The key objective is to deliver coherent and high-quality customer experience.

The need for new commercial models for the changing life sciences market, was also highlighted in an interesting article, published in the Pharmaceutical Executive on September 16, 2021. The authors identified six health care macro trends, demonstrating the value of transforming care delivery and shifting market behavior that prompt to reframe customer value propositions.

Taking a cue from this paper, I am listing below some of the current trends – as I see these and wrote before in this blog. Each one of these calls for well-connected data with analytics support:

  • Fostering a new genre of ‘customer-brand relationship’ to drive more targeted go‑to‑market strategies, enhanced agility/mobility of resources and highly personalized customer interactions.
  • Meeting the growing demand for value‑based care with novel risk‑adjusted and outcome‑based Price-Value-Models, supported by ongoing innovation in this area and sophisticated approach to value, affordability and outcomes.

Interestingly, despite Herculean constraints, many pharma players continued creating and delivering value, as the customers were expecting with changing situations.  

Drug-price sensitivity is increasing:

In the new normal, drug price sensitivity of customers is increasing manifold, for various reasons. A June 18, 2020 study, flags: ‘Nine in 10 Concerned About Rising Drug Costs Due to COVID-19.’ Although, this particular study (Gallup Poll) was conducted in the United States, general public apprehension is no different in other parts of the world, including India.

In my article of September 14, 2020, I also wrote that the concept of ‘fair pricing a drug’ is being deliberated by many experts around the world, since quite some time, till today. But it continues. Most recently, as reported on September 22, 2021, for different reasons related to its new Alzheimer’s drug - Aduhelm, including its hefty price tag of $56,000 annually per patient, ‘Biogen reps banned from D.C.-area neurology clinics.’

Regardless of such customer reactions, the pharma industry, as reported on September 17, 2021, continues to advocate – drug pricing pressure will stifle innovation, blocking patient access to needed medicines and dry up investment in important R&D on new therapies. Curiously, the Pharmaceutical Research and Manufacturers of America (PhRMA), is spending more than $1 million on TV ads as part of a massive lobbying and communications campaign emphasizing the potential harm to patients seeking cures for deadly diseases, as the report highlights.

Innovation – remained mostly unhindered from old to new normal:

Customers’ expectations can’t be ignored indefinitely. Interestingly, the world has also witnessed it with Covid drug and vaccine innovation continuing even during the most trying times during the pandemic, even in India. It is, therefore, quite understandable why unfettered access to drug innovation is considered an oxymoron, by many.

The good news is, despite shrill voices over pricing measures, the quest for adding meaningful value to the healthcare space continues unhindered. As reported on September 19, 2021, both Pfizer and Merck are advancing oral antiviral candidates targeting Covid-19 into late-stage testing. Thus, I reckon, regardless of jarring noise from pharma lobbyists, drug innovation, willy-nilly, has to satisfy the diverse demand of health care customers.

Innovation needs to satisfy demands of diverse healthcare customers:

That, increasingly, drug innovations will need to be based on their ability to satisfy the demands of life sciences companies’ diverse customer-perceived value-based, was also echoed by the Pharmaceutical Executive article of September 16, 2021.

While doing so, companies will need to structure innovation in terms of health outcomes, affordability, and personalization, as the paper emphasized. It further added, ‘broader definition of innovation means products are no longer the central driver of value.’ Instead, innovation will be powered by an increasingly diverse stream of data that resides outside the confines of the traditional health ecosystem.

Covid pandemic accelerated the transition of this process of innovation, drawing its new focus on providing a seamless and holistic customer experience in the disease treatment process – supported by advanced analytics and this deeper understanding of customer segments.

Conclusion:

Many pharma marketers have possibly undertaken a sophisticated and credible market scanning exercise in the new normal, to assess by themselves what have or haven’t changed in their customer preferences and market dynamics. If not, I would encourage them to initiate it, at least, now.

Equally noteworthy, as the above HBR article wrote, in the post pandemic period: ‘Beyond geography, marketing messages need to be personally relevant, aligned to an individual’s situation and values, as opposed to demographics, such as age and gender.’

The objective is to create a personal connection between the customer and the brand promotional content, aiming to influence the prescribing and purchasing behavior, based on their psychographic to attitudinal characteristics. This process would require creating and screening lots of customized data, supported by sophisticated analytics.

From the above perspective, I reckon, deep insight on what have or haven’t changed in the healthcare environment alongside its customers, would be of fundamental importance for pharma marketers, in the new normal.

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.