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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.

 

Criticality of Bridging the Skill Gap in Today’s Indian Pharma Industry

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To address the shortage of adequately skilled workers in the country, in 2023, the Government of India released a new version of the national skill development initiative called Pradhan Mantri Kaushal Vikas Yojana 4.0 (PMKVY 4.0). It is touted as a major upgrade over the previous versions of the scheme and aims to train 100 million people in different skills by 2024. This is expected to have a positive impact on the economy, creating new employment opportunities.

In this article, I shall deliberate on its current relevance in the Indian pharmaceutical industry. Let me start with some of the new features of this scheme and their relevance to the drug industry as I move on.

Some new features and details of the scheme:

As I see it, PMKVY 4.0 includes a number of new features and details over the previous versions, as follows:

  • A focus on high-demand skills: The scheme will focus on training people in high-demand skills, such as artificial intelligence, machine learning, and cloud computing.
  • A greater emphasis on apprenticeships: The scheme will encourage more apprenticeships, which will provide trainees with hands-on experience.
  • A focus on women and underrepresented groups: The scheme will make special efforts to train women and underrepresented groups.
  • A greater focus on quality: The scheme will have a stronger focus on quality assurance to ensure that trainees are getting the best possible training.

Similarly, the specific details of the scheme include:

  • The scheme will be implemented by the National Skill Development Corporation (NSDC).
  • The scheme will cover a wide range of skills, including IT, manufacturing, healthcare, and retail.
  • The training will be provided by a network of training providers, including government institutions, private training institutes, and industry partners.
  • The training will be free for all eligible candidates.
  • The scheme will also provide financial assistance to trainees to help them cover their living expenses during the training period.

Studies on the lack of a skilled workforce in the Indian pharma industry:

In tandem with the above, the lack of a skilled workforce in the Indian pharmaceutical industry has also emerged as a major concern in 2023. The industry is growing rapidly, creating a high demand for skilled workers.

Unfortunately, a huge shortage of adequately skilled workers keeps increasing. A contemporary study by the Indian Pharmaceutical Alliance found that the industry will need an additional 1 million skilled workers by 2025. Moreover, the National Skill Development Corporation (NSDC) has also identified the pharmaceutical industry as one of the top 10 industries facing a shortage of skilled workers. 

Factors contributing to this shortage:

Several factors have contributed to this shortage, including:

  • The rapid growth of the Indian pharmaceutical industry: The Indian pharmaceutical industry is growing at a rate of 10% per year. This rapid growth has created a demand for skilled workers that the industry is struggling to meet.
  • The increasing complexity of pharmaceutical manufacturing and marketing: Both are becoming increasingly complex, demanding employees with different skill sets. who have the knowledge and skills to operate complex equipment and follow strict procedures in the manufacturing process. Similarly, pharmaceutical marketing is also becoming increasingly complex due to the increasing number of regulations governing the industry, the growing importance of digital marketing, and the need to target a wider range of patients with varied demands and expectations. 
  • The lack of adequate training opportunities: There are not enough training opportunities available to meet the demand for skilled workers in the pharmaceutical industry. This is due to a number of factors, including the high cost of training and the lack of qualified trainers.
  • Mismatch between salary and expectations: There is often a mismatch between the salary offered and employee expectations. The average salary offered in pharmaceutical marketing is not as high as in other industries, such as technology. This makes it difficult to attract and retain skilled marketing professionals. 

The impact of the shortage of adequately skilled workers:

The shortage of skilled workers gives rise to negative consequences for the Indian pharmaceutical industry, such as:

  • Reduced productivity: The shortage of skilled workers is leading to reduced productivity in the pharmaceutical industry. This is because unskilled workers may lack the knowledge and skills to perform tasks efficiently.
  • Increased costs: The shortage of skilled workers is also leading to increased costs in the pharmaceutical industry. This is because companies have to pay higher salaries to attract and retain skilled workers. 
  • Quality problems: The shortage of skilled workers can also lead to quality problems in the pharmaceutical industry. This is because unskilled workers may not be able to follow GMP procedures correctly. Also, because unskilled marketing professionals may not be able to develop and implement effective marketing campaigns. 
  • Compliance issues: The shortage of skilled workers can also lead to compliance issues in the pharmaceutical industry. This is because unskilled workers may not be aware of the regulations that apply to the industry or the consequences of their violations on patients and society.

What the industry is doing today:

Some steps, though not considered enough by many, are being taken by the Indian pharmaceutical industry to address the shortage of skilled workers. Here are some specific recent examples:

  • Establishing training institutes: The industry is establishing training institutes to provide training to workers in the pharmaceutical industry. For example, the Indian Drug Manufacturers’ Association (IDMA) has established the IDMA Skill Development Institute in Hyderabad. The institute offers courses in pharmaceutical manufacturing, quality control, and regulatory compliance. 
  • Partnering with educational institutions: The industry is partnering with educational institutions to offer courses in pharmaceutical science and technology. For example, the Indian Pharmaceutical Alliance (IPA) has partnered with the National Institute of Pharmaceutical Education and Research (NIPER) to offer a diploma in pharmaceutical technology.
  • Promoting apprenticeships: The industry is promoting apprenticeships as a way to train workers in the pharmaceutical industry. For example, the Department of Pharmaceuticals (DoP) has launched the Apprenticeship Training Scheme for the Pharmaceutical Industry. Under the scheme, apprentices are paid a stipend and receive on-the-job training from experienced professionals.
  • Offering scholarships and grants: The industry is offering scholarships and grants to students studying pharmaceutical science and technology. For example, the IPA has launched the IPA Scholarship Scheme for Women in Pharmaceutical Sciences. The scheme provides scholarships to female students studying pharmaceutical sciences at the undergraduate and postgraduate levels.
  • Emphasizing on continuous learning: The industry is emphasizing on continuous learning for its employees. For example, several pharmaceutical companies offer their employees training programs and workshops on new technologies and regulations. 

Industry needs to work more closely with the government: 

The Indian pharmaceutical industry needs to work more closely with the government to address the shortage of skilled workers. The areas could possibly include:

  • Increasing the number of training institutes
  • Providing financial assistance to students studying pharmaceutical sciences
  • Relaxing the eligibility criteria for apprenticeships
  • Recognizing the skills of workers trained in other countries 

Where the government should take greater initiatives:

These areas may include the following:

  • Funding training programs
  • Partnering with educational institutions
  • Promoting apprenticeships

Conclusion: 

The shortage of skilled workers is a major challenge for the pharmaceutical industry. However, the industry is taking steps to address the challenge. There isn’t an iota of doubt in the contemporary pharma business environment that rebalancing the skill sets required, especially for employees in pharma sales and marketing, is more imperative today than ever before. Thus, it is important for the industry to continue to take steps to bridge the skill gap by addressing the shortage of its skilled workforce. This is essential today to maintain India’s position in the global market, at least as the reliable pharmacy of the world.

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 Prescription In Generic Names Only, No Branded Generics

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The World Bank Report released on April 07, 2023 highlights that patients’ Out-of-Pocket (OoP) expenses as a percentage of their total healthcare expenditure in India still accounted for as high as 50.59%. This means that patients in India generally pay for the majority of their healthcare costs themselves, rather than through insurance or government funding. The high level of OoP expenses in India has been a major problem for many patients, even today. Studies indicate it often leads to financial hardship, especially for low-income families.

A number of factors contribute to the high level of OoP in the country, as a whole, with regional variations. According to several studies, the healthcare costs in India are rising faster than inflation, making it increasingly difficult for more people to afford the care they need, especially for life threatening ailments, such as cancer.

Different union governments while in power have taken several steps to address this problem, such as, in 2018, the launch of the Pradhan Mantri Jan Arogya Yojana (PMJAY), a national health insurance scheme. It provides free coverage for poor and vulnerable families. The PMJAY is expected to have helped in reducing OoP for some patients, but it is not yet clear how much of an impact it has had overall.

On April 24, 2017, I asked on this blog – would drug ‘Prescriptions in Generic Names Be Made A Must in India?’. Interestingly, in August 2023, a new circular from the National Medical Commission (NMC) notified professional conduct regulations for Registered Medical Practitioners (RMP), including guidance to doctors on drug prescriptions.  This has raised a furor, as it were, among many medical practitioners and their associations. In this article, I shall deliberate on the pros and cons of this decision and its practicality in India. Let me start with the rationale behind such thinking, as I see it.

The rationales behind drug prescription only in generic names in India:

As I see it, there are several rationales behind doctors prescribing drugs only under generic names in India. Here are some of the most important ones:

  • Cost savings: Generic drugs are typically much cheaper than brand-name drugs. This is because generic drugs do not have to go through the same expensive clinical trials and marketing campaigns as brand-name drugs. As a result, they can be sold at a much lower price. This can save patients a significant amount of money, especially for expensive medications. 
  • Increased access to medicines: The lower cost of generic drugs can make them more accessible to people who might not otherwise be able to afford them. This is especially important in India, where a large proportion of the population lives below access, the poverty line. Generic drugs can help to ensure that everyone has access to the medicines they need. 
  • Improved competition: The availability of generic drugs can lead to increased competition in the pharmaceutical market. This can drive down prices even further and benefit patients.
  • Reduced risk of counterfeit drugs: Generic drugs are regulated by the government and must meet the same quality standards as brand-name drugs. This means that patients can be confident that they are getting a safe and effective product, regardless of whether it is a generic or brand-name drug. Counterfeit drugs, on the other hand, are often made with substandard ingredients and can be dangerous to take. By prescribing generic drugs, doctors can help to reduce the risk of patients getting counterfeit drugs. 
  • Transparency and accountability: In addition to these benefits, prescribing drugs under generic names can also help to promote transparency and accountability in the pharmaceutical industry. When doctors prescribe drugs under generic names, it is easier for patients to compare prices and choose the best option for their needs. This can help to drive down prices and improve the quality of care. 

A draft regulation was notified in 2022 for comments by all concerned:

For this purpose, a draft regulation was issued by the National Medical Commission (NMC) on May 23, 2022, for comments by all concerned, before it becomes mandatory in 2023. The NMC has also stated that it will take steps to ensure that the quality of generic drugs is maintained. The NMC will work with the Drug Controller General of India (DCGI) to ensure that generic drugs meet the required quality standards.

The final notification goes beyond drug prescription in generic names:

On August 03, 2023, The National Medical Commission (NMC) notified the professional conduct regulation for Registered Medical Practitioners (RMP). It not only provides guidance to avoid branded generic drugs and prescribing drugs with generic, non-proprietary and pharmacological names only, but also, restricts doctors from getting involved in any third-party educational activity like Continuing Professional Development, seminar, workshop, symposia, conference, etc., which involves direct or indirect sponsorships from pharmaceutical companies or the allied health sector. 

It justified its decision by saying, “India’s out-of-pocket spending on medication accounts for a major proportion of public spending on health care. Further, generic medicines are 30% to 80% cheaper than branded drugs. Hence, prescribing generic medicines may overtly bring down health care costs and improve access to quality care.” The notification also provided guidance on telemedicine consultation and prescriptions.  

The Indian Medical Association (IMA) Protested against it:

The Indian Medical Association (IMA) submitted a memorandum to the Indian regulator, the National Medical Commission (NMC), on February 7, 2023, protesting against the compulsory prescription of generic drugs. The memorandum argued that the regulations would harm patients and doctors, and that they were being implemented without proper consultation with stakeholders.

The IMA also stated that the regulations would violate the fundamental right to freedom of speech and expression of doctors. The memorandum said that doctors should be free to prescribe drugs based on their medical judgment, and that they should not be forced to prescribe generic drugs.

The IMA’s protest is significant because it is the first major challenge to the NMC’s regulations on compulsory prescription of generic drugs. The protest could have a significant impact on the implementation of the regulations, and it could also lead to changes in the regulations.

It is important to note that the IMA is not the only organization that has expressed concerns about the NMC’s regulations. Several other medical associations have also expressed concerns, and some doctors have also spoken out against the regulations.

The controversy over the NMC’s regulations is likely to continue for some time. It is important to note that there are valid concerns on both sides of the issue. It is also important to remember that the regulations are still in the early stages of implementation, and that it is too early to say what their long-term impact will be.

A few reasons why doctors in India may be hesitant to prescribe drugs under generic names. 

Here are some of the most common reasons:

  • Lack of awareness: Some doctors may not be aware of the benefits of generic drugs. They may believe that brand-name drugs are always better than generic drugs, even though this is not always the case. 
  • Influence from pharmaceutical companies: Pharmaceutical companies often give doctors incentives to prescribe their brand-name drugs. This can create a conflict of interest for doctors, who may be more likely to prescribe brand-name drugs even if they believe that generic drugs are just as effective.
  • Patient demand: Some patients may specifically ask for brand-name drugs, even if generic drugs are available. This can put pressure on doctors to prescribe brand-name drugs, even if they believe that generic drugs are a better option.
  • Quality concerns: There have been some cases of counterfeit generic drugs being sold in India. This can lead to doctors being hesitant to prescribe generic drugs, as they may be concerned about the quality of the drugs.

Some ways to encourage doctors to prescribe generic drugs:

  • Educate doctors about the benefits of generic drugs. Doctors need to be aware of the benefits of generic drugs in order to be willing to prescribe them. They should be taught about the cost savings, increased access, and improved quality of generic drugs.
  • Reduce the influence of pharmaceutical companies on doctors. Pharmaceutical companies should not be allowed to give doctors incentives to prescribe their brand-name drugs. This would help to ensure that doctors are prescribing drugs based on the best interests of their patients, rather than on financial considerations. 
  • Encourage patients to ask for generic drugs. Patients should be aware of the benefits of generic drugs and should ask their doctors to prescribe them whenever possible. This will help to create a demand for generic drugs and encourage doctors to prescribe them. 
  • Improve the quality control of generic drugs. The government should take steps to improve the quality control of generic drugs in India. This would help to reduce the risk of patients getting counterfeit drugs. 

By taking these steps, we can encourage doctors to prescribe generic drugs and make them more accessible to patients. This would help to save patients money, improve access to medicines, and reduce the number of counterfeit drugs in circulation.

Conclusion:

I now revert to this month’s notification of the National Medical Commission (NMC) on the professional conduct regulation for Registered Medical Practitioners (RMP), providing  new guidance for drug prescriptions in India. It clearly indicates that doctors should avoid prescribing branded generic drugs, instead prescribe drugs with generic, non-proprietary and pharmacological names only. ‘However, in the case of drugs with a narrow therapeutic index, biosimilars, and similar other exceptional cases, the practice of prescribing generic names only, can be relaxed,’ it elaborated.

Weighing the pros and cons of this notification, I reckon, despite the reasons articulated by doctors and their associations, besides the branded generic manufacturers, there are many benefits to prescribing drugs under generic names only. Generic drugs are typically much cheaper than brand-name drugs, and they are just as effective. They can also help to reduce the number of counterfeit drugs in circulation, besides several other benefits, as cited above. As a result, doctors should be encouraged to prescribe generic drugs whenever possible. Let me hasten to add, changing the prescribing practices of doctors and addressing concerns about the quality of generics can be a complex and gradual process.

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.

 

Meeting India’s Unmet Biologic Drug Needs Some Global Synergy Evident – But Patients Need More

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Many reports have vindicated the rapidly growing importance of biologic drugs in the treatment of a wide range of complex ailments. These include autoimmune diseases, cancers, hormonal irregularities, anemia, and to prevent various diseases such as vaccines, have drawn healthcare experts’ attention globally.

As defined by experts, Biologics are larger, more complex molecules compared to traditional small molecule pharmaceutical drugs. Unlike traditional pharmaceuticals, they require some components from a living organism to be manufactured.

The critical importance of biologic drugs lies in their ability to provide innovative treatment options, address unmet medical needs, and significantly impact patient outcomes in various disease areas. Towards this endeavor, a clear pathway for focused initiatives is warranted, especially in countries like India.

This article will explore this domain to get a sense of how much and how fast the country is progressing in this space, having huge healthcare significance, for all. Let me start with a quick recap on the areas of seminal importance of biologic drugs – to help all to be on the same page – as I start this deliberation.

The critical importance of biologic drugs:

The critical importance of biologic drugs, I reckon, lies in their unique properties and therapeutic potential:

Targeted Therapies: Designed to interact with specific molecules or receptors in the body, allowing for targeted treatment. This specificity can enhance the efficacy of the drug while reducing potential side effects on healthy cells and tissues.

Novel Treatment Options: Offer novel treatment options for diseases that were previously difficult to manage or had limited treatment options. They have revolutionized the management of conditions such as rheumatoid arthritis, psoriasis, multiple sclerosis, and certain types of cancer.

Personalized Medicine: Paving the way for personalized medicine, as it can be tailored to individual patients based on factors like genetic profiles or specific disease characteristics. This approach allows for more precise and effective treatment strategies.

Disease Modification: Unlike some traditional drugs that primarily alleviate symptoms, biologics can often modify the underlying disease process. They can target specific pathways or molecules involved in disease progression, potentially leading to long-term benefits and improved outcomes.

Improved Quality of Life: Has the potential to significantly improve the quality of life for patients living with chronic or debilitating conditions. By effectively managing symptoms and slowing disease progression, they can reduce pain, disability, and the need for other interventions.

It is important to note that biologic drugs are complex to manufacture, often require specialized infrastructure, and can be costly. No wonder why the India specific research paper - published on January 18, 2023 commented: “Although various biologic drugs are already available, they are still not within reach of the common person due to financial constraints.”  This prompts me to explore with examples some of the key issues that Indian patients confront while meeting this health need.

Patient access to original biologic drugs in India faces several key barriers:

Patient access to original biologic drugs in India faces several key barriers, including: 

1. Cost and Affordability:

- Trastuzumab (Herceptin): The cost of a single course of Herceptin, used in the treatment of breast cancer, can range from several lakhs to crores of rupees, making it financially burdensome for many patients in India.

- Eculizumab (Soliris): Eculizumab, used in the treatment of rare blood disorders, can cost several lakhs of rupees per month, making it unaffordable for most patients.

2. Limited Healthcare Coverage:

- Many health insurance policies in India have limitations or restrictions on coverage for expensive biologic drugs, requiring patients to bear a significant portion of the cost out of pocket.

- Some government-funded healthcare schemes, such as the Pradhan Mantri Jan Arogya Yojana (PMJAY), may have restrictions on coverage for expensive biologic therapies, limiting patient access.

3. Regulatory Barriers:

- The approval process for biosimilar versions of original biologic drugs could face delays in India. For example, the biosimilar version of Trastuzumab (Herceptin) faced delays in obtaining regulatory clearance, resulting in delayed patient access to more affordable alternatives.

- The regulatory requirements for original biologic drugs can be complex and time-consuming, leading to delays in drug approvals and subsequent patient access.

4. Limited Local Manufacturing:

- Drugs like Bevacizumab (Avastin) and Adalimumab (Humira) used in India are often imported, leading to supply chain challenges and potential delays in availability.

- Limited local manufacturing of certain original biologic drugs can result in dependence on imported versions, leading to potential pricing issues and supply disruptions.

5. Physician Awareness and Education:

- Some physicians may have limited awareness or familiarity with prescribing guidelines and clinical benefits of certain original biologic drugs. This can result in underutilization or hesitation in prescribing these therapies.

- Lack of specific training and education programs for physicians regarding the latest advancements in original biologic drugs can impact their knowledge and confidence in prescribing them.

6. Patient Education and Understanding:

- Patients may have limited knowledge about the availability and benefits of original biologic drugs. For instance, patients with chronic diseases like rheumatoid arthritis may not be aware of the benefits of newer biologic treatments over traditional therapies.

- Lack of patient education about the appropriate use and potential side effects of original biologic drugs can lead to hesitancy or misconceptions among patients, affecting their willingness to pursue these therapies.

These specific examples illustrate how cost, limited healthcare coverage, regulatory barriers, limited local manufacturing, physician awareness, and patient education can act as barriers to patient access to original biologic drugs in India.

Healthcare impact of inadequate access and availability of biologic drugs in India:

The inadequate access and availability of biologic drugs in India can have several significant healthcare impacts: 

Suboptimal Disease Management: Biologic drugs often provide highly effective and targeted treatments for complex diseases such as cancer, autoimmune disorders, and rare genetic conditions. The lack of access to these therapies can result in suboptimal disease management, leading to poorer patient outcomes, increased disease progression, and reduced quality of life for affected individuals.

Delayed or Incomplete Treatment: Inadequate access to biologic drugs can result in delays or interruptions in treatment. For chronic or progressive diseases, timely initiation and consistent use of these therapies are critical. Delayed or incomplete treatment can compromise the effectiveness of interventions, leading to prolonged disease activity, exacerbation of symptoms, and potential irreversible damage in some cases.

Increased Healthcare Burden: Without access to appropriate biologic therapies, patients may require more frequent hospitalizations, emergency room visits, or other healthcare interventions to manage their conditions. This can place an additional burden on healthcare systems, leading to increased healthcare costs and strain on resources.

Reduced Treatment Options: Biologic drugs often represent the most advanced and effective treatments available for certain diseases. Inadequate access to these therapies limits treatment options for patients, forcing them to rely on less effective or outdated treatments. This restricts the ability of healthcare providers to offer the best available care to patients, potentially leading to compromised treatment outcomes.

Health Inequity: Inadequate access to biologic drugs can exacerbate health inequities in India. Patients from lower socioeconomic backgrounds or those without sufficient insurance coverage may face greater barriers to accessing these expensive therapies. This can result in disparities in healthcare outcomes, with some individuals being unable to afford or access the best available treatments for their conditions.

Impact on Research and Innovation: Inadequate access to biologic drugs can hinder clinical research and innovation in India. Limited availability may reduce opportunities for conducting clinical trials and studying the effectiveness of these therapies in the local population. This, in turn, can hamper the development of new treatments and advancements in healthcare.

Addressing the inadequate access and availability of biologic drugs is crucial to ensure equitable healthcare outcomes, optimize disease management, and reduce the burden of complex diseases in India.  

Increasing need for biosimilar drugs in India and issues involved:

From the above perspective, increasing the availability of biosimilar drugs in India is crucial. Fostering competition may improve affordability. Thereby, it would increase access to essential therapies – bridging treatment gaps, disease management, healthcare system sustainability and foster market competition and innovation.

However, it can ensure that patients receive appropriate and effective treatments while addressing the healthcare challenges faced by a diverse population, only when some key barriers created for biosimilar drug entry, besides patent thickets, are also adequately addressed. One such way is creating a global synergy in this space by collaborating with MNC pharma – having deep pockets and other requisite wherewithal.

Some global synergy is evident in this critical healthcare space:

The good news in this space has started flowing. There have been several collaborations between multinational pharmaceutical companies (MNCs) and domestic Indian drug companies to develop even high potential interchangeable biosimilar drugs in India. Here are a few examples:

- Biocon and Mylan: Biocon has collaborated with Mylan, a global pharmaceutical company, to develop and market biosimilar products. This collaboration has resulted in the development and approval of biosimilar drugs such as Trastuzumab (Herceptin) and Adalimumab (Humira) in India. 

- Dr. Reddy’s Laboratories and Merck: Dr. Reddy’s Laboratories, an Indian multinational pharmaceutical company, entered into a collaboration with Merck & Co., a global pharmaceutical company, to develop biosimilar versions of biologic drugs. This collaboration has resulted in the development and launch of biosimilars such as Pegfilgrastim (Neulasta) and Rituximab (Rituxan) in India.

- Cadila Healthcare and Novartis: Cadila Healthcare, an Indian pharmaceutical company, collaborated with Novartis, a multinational pharmaceutical company, to develop and manufacture biosimilars. This collaboration has resulted in the development of biosimilar drugs such as Rituximab (Ritucad) and Bevacizumab (Bevatas) in India.

These are just a few examples of collaborations between MNCs and Indian drug companies in the field of interchangeable biologic drugs. The landscape of collaborations and partnerships in this area is dynamic, and there may be more ongoing collaborations between companies to develop and commercialize biosimilars in India.

Conclusion:

Overall, patient access to biosimilar drugs in India is crucial for ensuring affordable and comprehensive healthcare, improving patient outcomes, and promoting a competitive pharmaceutical market. It helps address the challenges of access and affordability of biologic drugs, ultimately benefiting the well-being of patients across the country – promoting healthcare equity, and the sustainability of the healthcare system in the country. But patients need more…much more.

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.

Exploiting India’s Weakness For Monopolistic Commercial Gain?

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Public access to healthcare in India is a complex issue with several challenges. While India has been making progress over the years in improving healthcare access and reducing the burden of disease, there are still significant disparities in healthcare access and outcomes across the country. The three primary barriers continue to remain:

  • Affordable access to quality healthcare: This arises out of the shortage of healthcare infrastructure and resources, more in rural areas. The shortage includes an inadequate number of doctors, nurses, and other healthcare professionals, as well as inadequate facilities and equipment.
  • Cost of healthcare: While India has a largely publicly funded healthcare system, the quality of care in public hospitals is often poor, and many people are forced to opt for private healthcare, which can be expensive.
  • Access to affordable drugs: Despite India being a major producer of generic drugs, many people in India still lack access to essential medicines. This is due in part to the high cost of branded medicines, which are often out of reach for many people, as well as a lack of availability of certain medicines in some areas.

Undoubtedly, this remains a weak area for the country, till date. Successive Indian governments have taken steps to address these challenges. However, public funding on healthcare as a percentage of GDP and implementation of policies to increase access to medicine, continue to remain below par. Much work needs to be done to ensure that all people have access to quality healthcare and essential medicines.

Amid this situation, especially on the international political front, drug MNCs are continuously blaming India for the fact that the Indian Patents Act is not robust enough to protect their drug patents on NMEs and technologies. For example, in its 2022 Special 301 Report, the USTR designated seven countries on the Priority Watch List. These are Argentina, Chile, China, India, Indonesia, Russia, and Venezuela. To give some more examples from the available reports:

  • In February 2021, PhRMA, a trade group representing multinational pharmaceutical companies, raised concerns about India’s policies related to IP rights and access to medicines. PhRMA argued that India’s policies were undermining innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 
  • In March 2021, Pfizer’s CEO also expressed concerns about India’s policies related to IP rights and access to medicines. He said that Pfizer was facing challenges in obtaining patents for its products in India, and that the lack of adequate patent protection was discouraging investment in research and development.
  • In May 2021, Novartis’s CEO criticized India’s policies related to IP rights and access to medicines. HE stated that the lack of adequate patent protection in India was discouraging innovation and investment in the pharmaceutical industry, and that multinational pharmaceutical companies were facing difficulties in doing business in India. 

Against this backdrop, in today’s article I shall deliberate on this vexing issue – starting from some key grievances of drug MNCs in this regard. Thereafter we will look at the Indian industry response to drug MNCs’ concern about the robustness of the Indian Patents Acts. This could possibly help us to understand the key question – Is it then an attempt to exploit India’s weakness regarding inadequate overall access to medicines for monopolistic gain by the vested interest?

Key grievances of drug MNCs for poor access to medicines in India: 

One can recall that the Patent Act in India was amended in 2005 to comply with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement. The amendment made it more difficult for multinational pharmaceutical companies to obtain patents for their products in India for the ‘me too’ type of innovation, which has led to lower prices for medicines and increased access to affordable drugs for the Indian population.

However, drug MNCs generally argue that:

  • The lack of adequate patent protection in India discourages innovation and investment in research and development, which ultimately limits the availability of new drugs for patients in India.
  • They have also criticized the Indian government’s use of compulsory licensing, which allows the government to authorize a third party to produce a patented drug without the consent of the patent holder. They argue that this undermines their intellectual property rights and discourages investment in research and development, which ultimately limits access to new and innovative drugs for patients in India.

Counter argument by Indian companies:

Indian companies, on the contrary, defend their position and policies related to access to medicines and healthcare in India, and have responded to the accusations made by drug MNCs in the following ways:

  • Provides adequate patent protection: The Indian Patents Act provides adequate IP protection, in accordance with the TRIPS agreement. They have also pointed out that the patent laws in India allow for the grant of patents for genuine inventions, while preventing the grant of frivolous or secondary patents (the me-too types), which can result in excessive monopolies and high prices for medicine. 
  • Encourage innovation: Indian policies have not discouraged innovation in the pharmaceutical industry. They have pointed out that Indian companies invest heavily in research and development and have developed several innovative drugs that have been approved by regulatory authorities in India and around the world. 
  • Rare occurrence of Compulsory licensing: The use of compulsory licensing is a legitimate tool under international law and is aimed at promoting public health and ensuring that life-saving drugs are accessible and affordable to patients in India. They have also pointed out that the use of compulsory licensing is a rare occurrence in India and is only used in exceptional circumstances.

Overall, Indian drug companies have emphasized their commitment to improving access to medicines and healthcare in India, while ensuring that their policies are in line with international laws and regulations. They have also emphasized the need for collaboration and dialogue with multinational pharmaceutical companies to find mutually acceptable solutions that benefit patients in India and around the world.

Examples of innovative drugs developed by Indian drug companies:

It’s interesting to note that in the same IP scenario, Indian companies with limited resources, are developing innovative drugs that have been approved by regulatory authorities around the world. Here are a few examples, as reported at different times:

  • Lipaglyn: Developed by Zydus Cadila, Lipaglyn is the first-ever drug approved for the treatment of diabetic dyslipidemia. It has been approved in India and several other countries, including the European Union. 
  • Tafinlar: Developed by Dr. Reddy’s Laboratories, Tafinlar is a kinase inhibitor that has been approved by the US FDA for the treatment of advanced melanoma. 
  • Mycapssa: Developed by Sun Pharma, Mycapssa is a novel oral formulation of octreotide, a hormone therapy used to treat acromegaly. It has been approved by the US FDA. 
  • Saroglitazar: Developed by Zydus Cadila, Saroglitazar is a dual PPAR agonist that has been approved in India for the treatment of diabetic dyslipidemia and non-alcoholic fatty liver disease (NAFLD). 
  • Nexavar: This much discussed drug, originally developed by Bayer and by Natco Pharma, is a kinase inhibitor that has been approved by the US FDA for the treatment of liver and kidney cancers.

Conclusion:

The IP issues keep haunting India and are being captured in different Special 301 Reports of the USTR, even after The Indian Patents Act 2005 came into force – till 2022. Any change to this Act seems very unlikely now as this is an important piece of legislation that helps balance the interests of protecting intellectual property, promoting innovation and access to affordable medicines. Any dilution of this Act could have negative consequences for India and its citizens.

From this perspective, I reckon, any further pressure in this area may be construed as an attempt to exploit India’s weakness of inadequate access to medicines for monopolistic gain by vested interests. 

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.

Impact of The Cost of Pharma Marketing Failure On Patients

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‘About half of all products launched over the past 15 years have underperformed pre-launch consensus forecasts by more than 20%.’ It’s one of the findings of a recent study by L.E.K. Consulting, going back to 2004. This number is besides the cost of failure while discovering a successful New Molecular Entity.

Adding this to the cost of the product innovation and development, clinical trials and other regulatory expenses, the wasteful expenditure becomes mind boggling – for any unsatisfactory launch performance. In such a situation, the probability of creating newer blockbuster therapies is not getting any easier.

As is believed by many – and vindicated by several studies, new drug marketing cost is more than its R&D cost. Which is why, ensuring success of a new drug launch is critical to fund new drug innovation – on an ongoing basis. Consequently, leadership focus on high ‘launch success’ rate is so important – as the good old saying goes – ‘well begun half done.’

In addition, prudent optimization of the success rate of new products may also help the company avoid irresponsible pricing, while improving the profit margin. In this article, I shall deliberate on the impact of the cost of marketing failure on patients, in general. Alongside, the avoidable ‘soft ground’ that marketers may wish to avoid while delivering unmet value to patients.

Big Pharma’s Sales and Marketing spend is more than R&D:

According to another recent study of October 27, 2021, ‘in most cases, more of the dollars spent by drug manufacturers go toward selling and marketing costs than toward research and development (R&D) for new treatments, cures, or expanded indications and uses of existing drugs.’ For example, as the paper highlights:

  • AbbVie, which manufactures branded drugs like Humira, spent $11 billion in sales and marketing in 2020, compared with $8 billion on R&D.
  • Bayer, which manufactures branded drugs like Xarelto (codeveloped with Johnson & Johnson) and Eylea, spent $18 billion in sales and marketing, compared to $8 billion on R&D.
  • Johnson & Johnson, which manufactures branded drugs like Xarelto (codeveloped with Bayer) and Stelara, spent $22 billion on sales and marketing, compared to $12 billion on research and development.

Therefore, just as R&D expenses have to be made more productive, so are the sales & marketing expenses, where the expenditure towards new product launches is a critical component.

Why a successful new product launch is important:

An analysis by Deloitte in this area, published on March 26, 2020, found that most new drugs continue with the revenue trajectory set at launch. It said, about 70 percent of products that miss expectations at launch continue doing so in subsequent years, and around 80 percent of products that meet or beat expectations continue to do so afterward. Thus, launch success of a new product is very important, both for the organizations and the patients.

A successful new product launch helps both the company and patients:

Correctly assessing and leveraging full commercial potential of a new product through its effective launch helps both the patients and the company. This subject was discussed in a recent article, published in the Fierce Pharma on October 25, 2021, in the context of many drug launch disasters. The areas of benefits, I reckon, include the following:

  • Patients’ unmet needs are met at a reasonable price
  • Manufacturer can recoup its research and development costs.
  • Fund future drug discoveries.
  • Satisfy investors with handsome returns.
  • Creating a sound brand performance base – as a strong launch is arguably the most critical step in a new drug’s lifecycle.

New product launch failure is across the disease areas – from Big Pharma to Startups:

As the above December 18, 2020, study by L.E.K. Consulting points out that new products’ launch failure is taking place across the disease areas. These include,  Oncology, immunology, infectious disease, ophthalmology, blood disorders, brain diseases, and cardiovascular and metabolic disease. Similarly, the companies responsible for such failure span across global pharma majors to biotech startups.

Why many companies are failing in this process:

To help ascertain the depth of this issue, let me start with the key objective of a new product launch, which is effectively delivering the holistic value of the brand which consumers would appreciate. Several papers also acknowledge, to succeed in this area, pharma players need to prepare their data-based launch plan with cerebral power and ensure that the strategy is working and is being executed flawlessly.

A large number of studies find, ‘many companies fail in this process, due to a combination of factors.’ Some of these are uncontrollable, but many of which are very much within a marketer’s control.

Examples of uncontrollable and controllable variables:

Uncontrollable factors include post marketing approval drug safety issues. Reports indicate, ‘One-Third Of New Drugs Had Safety Problems After FDA Approval.’ This is being reported even in recent times, like, ‘new safety signals that cropped up after the approvals of Novartis’ eye drug Beovu  and Sanofi’s dengue vaccine Dengvaxia.’

Whereas, controllable factors include, poor product differentiation and other management missteps, besides ‘limited market access, poor understanding of market needs or misjudgment of competitive threats.’ For example, poor product differentiation and other management missteps were, reportedly, ‘the cause of trouble for Clovis Oncology’s Rubraca in the PARP inhibitor space, and Merck & Co. and Pfizer’s Steglatro in the SGLT2 field.

Key success ingredients to focus on:

Since long, various research, including one by Bain & Co dated October 2017, has highlighted that over 50% of new product launches are underperforming. This situation can’t, in any way, be accepted as a ‘thumb rule’ by pharma marketers, any longer.  Mainly because: ‘When a drug misses its launch projections, there’s a high likelihood that it will never recover that revenue,’ as their study findings underscore. From this perspective, listed below are some of the basic areas to focus on for greater launch success, as I have experienced:

  • Early launch planning – well before the regulatory approval for new products.
  • Data-based and well-tested target-audience identification, the target markets’ selection and key opinion leaders need to be selected for greater focus in effective stakeholder engagement.
  • Creating differentiated value-propositions that addresses targeted patients’ unmet needs, and, in tandem, offers scope for commensurate premium pricing, are vital.
  • Product pricing should be based on quality of value delivery to patients that they can perceive and would acknowledge. Misvaluing a brand, and just focusing on those who can pay, may attract negative publicity, creating a key barrier to success.
  • Current competition, their ongoing counter strategy, new market competitors and other launch challenges need to be carefully mapped, for strategic fine tuning or course correction, in time, wherever and whenever needed.
  • Execution of the launch plan must be accomplished with military precision, as it were.

Conclusion:

As the above Bain & Co paper articulated, ‘The most consistently undervalued factor contributing to a successful launch is the way leadership teams organize and the manage the launch process.’

It’s again not too difficult to understand that the net accountability of the cost of marketing failure, which is a major contributing factor to stifle the R&D funding, in many cases, squarely falls on pharma leadership.

Instead of taking corrective action in this critical area, most of them choose the easy path – increase new product pricing to achieve targeted revenue from a smaller unit sale of the brand. The net impact of which is on patients due to access barrier caused by high prices.

Such products, without clearly differentiated value propositions that patients would recognize, would further increase sales and marketing costs, and could even result in marketing malpractices. Under this backdrop, serious and thoughtful attempt in making all new product launches successful money spinners, as respective brands will merit, may help the pharma leadership to create a win-win situation for both the company and 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.

 

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.

 

 

India Being World’s Third largest Covid Vaccine Maker: Will All Indians Benefit?

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Apprehensions on the time of availability notwithstanding, equitable access to Covid vaccines for all, remain the best hope to leash the deadly virus, as the pandemic overwhelms the world. According to the World Health Organization (WHO) ‘Coronavirus Update 37’ of October 06, 2020, as of October 02, 2020, there are 42 COVID-19 candidate vaccines in clinical evaluation of which 10 in Phase III trials.

Recently, the article, published in the Harvard Business Review on April 02, 2020, also flagged this critical area – ‘A Covid-19 Vaccine Will Need Equitable, Global Distribution.’ The paper highlighted: ‘The time to prepare for globally distributing a Covid-19 vaccine in a way that is effective and equitable is now. It will have a long-term payoff by helping to prevent future pandemics, which scientists predict will be more common as the earth’s climate warms.’

Even Bill Gates’ article, published in The New England Journal of Medicine (NEJM) on February 28, 2020, expressed a similar apprehension. The article is titled - ‘Responding to Covid-19 – A Once-in-a-Century Pandemic?’ Gates also articulated: “During a pandemic, vaccines and antivirals can’t simply be sold to the highest bidder. They should be available and affordable for people who are at the heart of the outbreak and in greatest need. Not only is such distribution the right thing to do, it’s also the right strategy for short-circuiting transmission and preventing future pandemics.”

He too urged all concerned to ensure that during a pandemic, vaccines and antivirals aren’t ‘simply be sold to the highest bidder.’ On the contrary, these should be made available, affordable and accessible to all. ‘Not only is such distribution the right thing to do, it’s also the right strategy for short-circuiting transmission and preventing future pandemics,’ he asserted.

Does any authority pay heed to these suggestions? The question remains unanswered. Interestingly, on September 17, 2020 by a Press Release, Oxfam International reported, ‘leading wealthy nations representing just 13 percent of the world’s population have already cornered more than half (51 percent) of the promised doses of Covid-19 vaccine candidates.’ This is regardless of where these vaccines are manufactured, including India.

These prompt one to wonder, ‘Would India’s possible rise as the world’s third largest vaccine manufacturer benefit all Indians, with affordable and equitable access to Covid prevention shots? In this article, I shall dwell in this area.

India emerges as the world’s third largest Covid vaccine producer:

According to August 24, 2020 edition of the Nature publication, if all of the frontrunner candidates of Covid vaccines are approved, more than 10 billion doses could be available by the end of 2021. Most of these vaccines will be made in the North America and Europe. The top Covid vaccine manufacturing countries are estimated to be the United States, followed by the United Kingdom, India, Norway and France, the report highlights.

However, wealthy countries have already struck deals to buy more than two billion doses of Coronavirus vaccine in a scramble that could leave limited supplies in the coming year. For example, as the above Nature article indicates, publicly announced estimated capacity to 2021 of Oxford/AstraZeneca Covid vaccine, is 2.94 billion. Interestingly Serum Institute of India (SII) signed an agreement to manufacture over I billion doses in 2021.

Whereas, another report of September 29, 2020, stated that SII will make available 200 million doses by 2021, at $3 dose to a group of at least 62 ‘low- and middle-income countries (LMIC)’ that includes India. This arrangement does not make clear how many of the 200 million doses will be made available in India. Curiously, SII reportedly, is also one of the global partners for the production of Britain’s Covid-19 vaccine on a large scale, once it gains regulatory approval.

Growing ‘vaccine nationalism’ needs to be prevented:

Thus, if one looks at the macro picture, a small group of rich nations, representing just 13 percent of the global population has bought 51 percent of the supply of leading Covid-19 vaccine contenders, according to the above Press Release of Oxfam International.

Many public health experts have expressed grave concern on such developments. They have also articulated in multiple forums that the world is not going to get rid of the pandemic until it gets rid of Covid-19 from everywhere. Terming this approach vaccine nationalism, the Director General of the World Health Organization (WHO) urged all concerned, at his August 18, 2020 briefing that this needs to be prevented by all, urgently.

No clarity yet, on whether the vaccine will be free for all Indians:

Although, there is no reported ‘vaccine nationalism’ in India, thus far, for understandable reasons, there isn’t any clarity, either, on whether Covid vaccines will be free for equitable access to all in India. As reported on October 27, 2020, Dr. V.K. Paul of NITI Aayog, who heads the Centre’s expert committee on vaccines confirmed this by saying:

“We’ll have more clarity in the weeks ahead when trial data from the ongoing trials (phase 3) of the Serum Institute of India (which is testing the Oxford AstraZeneca vaccine) is available. The success of it and the other candidates will determine the availability and the dosage required and then we can discuss financing.”

Interestingly, free Covid vaccination for all in Bihar, has featured in ruling party’s the election manifestos, if they win the recent state assembly poll. This raises a doubt for the common man, whether or not this vaccination will be free to all in other states, as well, where such promises are not being made.

Ambiguity also on how much it will cost to the nation:

As on date, avoidable ambiguity prevails in many areas of Covid-19 vaccination process in India, for various reasons. For example, ‘Will India have Rs 80,000 crore for Covid-19 vaccine,’ asked the top vaccine maker in India, on September 27, 2020. Whereas, as reported on October 23, 2020, ‘the government has set aside about Rs 50,000 crore ($7 billion) to vaccinate Indian citizens.’

The same report also wrote, the Coronavirus vaccine, once available, will be distributed under a special Covid-19 immunization program. The Centre will procure the vaccine directly to make it available to the ‘priority groups’ free-of-charge through the existing network of states and districts. States have been asked not to chart separate pathways of procurement. This is expected to coveraround 25 Crore people by July next year, according to the Union Health Minister of India.

This also appeared in the Bloomberg/Quint article of October 17, 2020. It reported, India is identifying 300 million people who will receive the initial dose of a coronavirus vaccine. Priority will be given to workers in high-risk sectors such as police, health care, sanitation, elderly people and those with co-morbidities. The beneficiaries of vaccine in the first phase will receive an estimated 600 million doses and implementation plan aims to cover over 23 percent of the population.

Assuming that Rs. 50,000 Crore will be the vaccination cost for only 23 percent of the Indian population, what will it cost to nation to vaccinate 100 percent of the population against Covid? How will rest of Indians get access to Covid vaccination? Will the citizens be inoculated sans any out of expenditure for the same? If so, why free Covid vaccination has been promised only for Bihar, in the recent Assembly election, only in case the ruling party returns to power, as stated above?

Humongous logistics challenge for India: 

Even if, India plans to administer Covid-19 vaccine to just 23 percent of the population, covering its high-risk population, across the country, in the first half of 202, it will involve 400-500 million doses. Will SII be able to deliver so many doses by June 2020? However, maintaining uninterrupted ‘cold chain’, in the entire logistics process – including local transportation and storage, wherever required, till these are administered to people, will be a humongous task for India.

While the required storage temperature of Oxford-AstraZeneca vaccine is -20 degree Celsius, some of the most promising candidates, such as, Moderna and Pfizer-BioNTech’s Covid-19 vaccines need to be stored at as low as -80 degrees Celsius, till administered.  

Covid vaccination cost is not just the cost of a vaccine:

To vaccinate 1.3 billion people of India, the Government needs to train in advance, a large number of health workers to accomplish the task. Alongside, the supply chain, including a demanding and uninterrupted countrywide ‘cold chain’ will also need to factor in other costs. These will include, availability of ancillary items like syringes, among others.  The complexity of vaccine logistics further increases manifold, as 70 percent of the country’s population lives in rural India. Thus, the net outlay for Covid vaccination will be much more than a vaccine cost.

What happens, if these are not achieved with military precision, much before vaccine manufacturing commences? In that case, I reckon, it is quite likely that efficacious COVID -19 vaccines may not be made accessible even to 23 percent of the high-risk people, such as police, health care and sanitation staff, elderly people and those with serious co-morbidities.

Conclusion:

The economic, social and health care concern over Covid pandemic continues in India. As of November 01, 2020 morning, India recorded a staggering figure of 8,184,082 of Coronavirus cases with 122,149 deaths. During this health crisis, among several other critical areas, India is also still learning – the hard way, how fragile is its public health care infrastructure. Covid pandemic has possibly caused the worst ever health care catastrophe in the country, due to years of negligence – that continues even today.

Besides above legacy issues, meager deployment of resources, low overall health awareness for Covid, inadequate number of health care personnel, insufficient Covid testing kits to detect the virus and prevent it from spreading, is still playing havoc. Moreover, many epidemiologists continue to suggest that India’s real infection rates are far higher.

In this setting, if, as and when subsequent Covid waves will strike, the number of cases is likely to grow exponentially – again. Thus, inoculating the entire population with Covid-19 vaccines is the most desirable way out, for India to prevent this health calamity from lingering too long. As Mark Feinberg, head of the International AIDS Vaccine Initiative in New York City had said in the August 24, 2020 edition of Nature publication: “We’re not going to get rid of the pandemic until we get rid of it everywhere.”

Here comes the importance of equitable access to Covid vaccination for all in India. Although, a number of international organizations, including the W.H.O and Gavi, are working hard to reduce this threat, the concern over inequitable access to Covid vaccines, still remains a real one. Intriguingly, despite India being positioned as the world’s third largest Covid-19 vaccine producer, no one is still sure due to multiple reasons, whether all Indians will benefit from it – probably not even the Government of 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.