The Indian Drug Industry’s Looming Talent Crisis – A Recent Landscape

India’s pharmaceutical industry, a global generics and drug manufacturing powerhouse, is facing a critical talent deficit. The shortage of skilled professionals is impeding innovation, drug development, and the industry’s overall competitiveness.

This challenge, exacerbated by recent industry dynamics, demands immediate attention to unleash the sector’s full potential. In today’s article, I shall dwell on this area.

Talent challenges and focus areas:

The industry is facing a significant talent crunch. Here’s a breakdown of the key challenges with recent, specific examples:

1. Skill Shortage:

The industry demands expertise in areas like regulatory affairs, data science for clinical trials, biosimilars, and gene therapy. However, the current education system and skill development programs haven’t kept pace with this evolving landscape.

Example: A 2023 report by TeamLease points out a growing demand for professionals with expertise in regulatory affairs, particularly, those adept at navigating international regulations for drug approvals. This is crucial as Indian companies increasingly target overseas markets.

2. The Great Resignation Impact:

Example: A 2024 article in The Economic Times highlighted a recent exodus of mid-level managers from several Indian pharma companies. The report cited factors like stagnant salaries, lack of growth opportunities, and a competitive job market as reasons for the increased job hopping.

3. Competition for Talent:

Example: A recent news piece in BioSpectrum Asia (May 2024) discussed the fierce competition for experienced professionals in the biosimilars space. Companies like Biocon and Reliance Life Sciences are aggressively hiring and offering lucrative packages to attract top talent in this rapidly growing field.

4. Lack of Industry-Academia Collaboration:

Example: A joint report by FICCI (Federation of Indian Chambers of Commerce and Industry) and Ernst & Young (2023) highlighted the growing gap between the skills taught in universities and the practical needs of the pharma industry. The report urged closer collaboration between industry and academia to ensure curriculum updates reflect current industry requirements.

5. Diversity Issues:

Example: A 2024 study by Express Pharma revealed that despite comprising a significant portion of the workforce, women hold only around 15% of leadership positions in the top 20 Indian pharmaceutical companies. This highlights the need for targeted initiatives to promote women into leadership roles.

In such a scenario, some may obviously ask, what is my recommendation or the ways some companies are trying to address this issue. Here below is my prescription:

A prescription – A Multi-Pronged Approach, with Indian examples: 

Re-skilling and Up-skilling:

Example: Dr. Reddy’s Laboratories, reportedly launched targeted training programs to equip existing employees with data science skills for clinical trial design and analysis. This approach empowers the current workforce and addresses the immediate skill gap.

Industry-Academia Collaboration:

Example: Lupin, as reported, partnered with IIT Delhi to establish a joint research center focused on drug delivery systems. This collaboration bridges the gap between academic knowledge and industry applications, better preparing graduates for real-world challenges.

Fostering Diversity and Inclusion:

Example: According to reports, Biocon’s “Women in Biopharma Leadership” program provides mentorship, training, and networking opportunities for aspiring women leaders. This initiative tackles the under-representation of women in leadership roles and unlocks the industry’s full talent potential.

As I discussed in my earlier article, ‘Diversity And Inclusion: A Missing Link For Indian Pharma‘ (June 25, 2018), the Indian pharma industry faces a critical talent shortage.

Building a Strong Employer Brand:

Example: Companies like Cipla can invest in employer branding initiatives to showcase their work culture, growth opportunities, and commitment to diversity. This can attract talent seeking a fulfilling career path and a positive work environment.

Leveraging Technology: Implementing AI-powered talent acquisition platforms can streamline recruitment processes and identify suitable candidates from a wider pool, including those from non-traditional educational backgrounds.

Conclusion:

By addressing these challenges through strategic investments in skill development, nurturing industry-academia partnerships, and fostering a more inclusive work environment, the Indian pharmaceutical industry can build a robust and future-proof talent pool. This will be equipped to drive innovation and ensure its continued success in the global market to maintain its competitive edge, sustainably.

By: Tapan J. Ray

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

 

UCPMP 2024: Game Changer or False Dawn?

On March 12, 2024, the Department of Pharmaceuticals (DoP) of the Government of India notified the new Uniform Code for Pharmaceutical Marketing Practices (UCPMP) 2024.

Having gone through the details, many construe that aiming to finally clean up pharmaceutical marketing practices in India, as demanded by many stakeholders – including the Supreme Court of India, the new one released by the DoP in March 2024 still appears to be a ‘work in progress.’ One therefore, wonders whether UCPMP 2024 is a step forward or status quo in establishing desirable standards for pharma business ethics in India.

In this article, let me dwell on this issue, highlighting examples of some key points in this regard.

Some key points to take note of:

There are several key points to take note of some examples, which will include:

  • Unlike its predecessor, the 2024 UCPMP removes the word “voluntary” but doesn’t explicitly make the code mandatory. It requests industry associations to implement the code.
  • The code doesn’t explicitly prescribe penalties for pharmaceutical companies beyond removal from industry associations (if they are members).
  • Doctors who violate ethical codes can face license suspension and fines under the National Medical Commission (NMC) guidelines. However, the NMC’s stricter 2023 code revisions were put on hold due to industry pressure.

Thus, several issues, including the following, need to be answered, beyond any ambiguity whatsoever. That said, let me start with how the UCPMP 2024 brings both opportunities and challenges for Indian drug companies, and then we will try to fathom whether the new code as it presents today will prove to be a game changer to improve the quality of ethical standards, especially, in Indian pharmaceutical marketing. 

UCPMP 2024 – some key challenges for drug companies:

A.  Marketing Revamp:  The new UCPMP demands a complete overhaul of marketing practices and strategies. Companies need to find new, compliant ways to educate doctors about their products, likely focusing on:

  • Scientific Data and Value Proposition: Stronger clinical trial data and highlighting a drug’s actual benefits will be crucial.
  • Transparency and Credibility: Building trust with doctors through clear, accurate information and high-quality educational materials is essential.

B.  Salesforce Transformation: Medical representatives, previously reliant on personal connections, now need expertise in:

  • Scientific Communication: Effectively engaging doctors with the science behind the drug.
  • Product Knowledge: Deep understanding of the drugs they are promoting.
  • Potential Sales Slump: Stricter marketing might lead to a decline in sales, particularly for established brands that rely heavily on promotion. Companies need to adapt their sales strategies to address this.

Effectively navigating these challenges requires significant investments in:

  • R&D: Stronger focus on research and development to create innovative drugs with a clear value proposition.
  • Data-Driven Marketing: Utilizing data science to understand doctor needs and target marketing efforts effectively.
  • Salesforce Training: Upskilling representatives in scientific communication and product knowledge.

By adapting their approach, Indian drug companies can leverage UCPMP as an opportunity to move towards a model focused on the quality and scientific merit of their products.

UCPMP 2024 – some key opportunities for drug companies:

The UCPMP 2024, while presenting challenges, also offers some key opportunities for Indian drug companies to thrive:

  • Level Playing Field: The ban on gifts and incentives removes an unfair advantage for larger companies. This allows smaller or generic drug companies to compete based on the merits and affordability of their products.
  • Focus on Innovation: With less emphasis on promotion, companies may be incentivized to invest more in R&D, leading to the development of new, innovative drugs with stronger scientific backing.
  • Building Brand Trust: Transparency and accurate information mandated by UCPMP can help companies build trust with doctors and patients alike. This strong reputation can be a valuable asset in the long run.
  • Data-Driven Marketing: The shift towards data-driven marketing allows for targeted communication based on doctor needs and preferences. This can be more cost-effective and lead to better engagement with healthcare professionals.
  • Focus on Patient Education: UCPMP encourages companies to provide clear information directly to patients. This can empower patients to make informed decisions about their healthcare and potentially increase the demand for effective medication.

By capitalizing on these opportunities, Indian drug companies can:

  • Differentiate themselves: By focusing on innovation and patient-centricity, they can carve out a niche in the market.
  • Building long-term value: Investing in R&D and building trust with doctors can lead to sustainable growth and brand loyalty.
  • Becoming more competitive globally: A focus on innovation and scientific merit can help Indian companies compete effectively in the international pharmaceutical market.

Interestingly, the UCPMP presents a chance for Indian drug companies to move away from an outdated marketing model and embrace a more ethical and sustainable approach. By focusing on innovation, data-driven marketing, and building trust, they can seize this opportunity to become leaders in the global pharmaceutical industry.

Is UCPMP 2024 a game changer or a false dawn?

Having said all this, the question still remains whether UCPMP 2024 is a game changer or a false dawn. I reckon, while aiming to curb unethical practices in the pharmaceutical industry, questions linger about its effectiveness. Let’s delve into both sides of the argument:

A Game Changer:

  • Stronger Stance: The removal of “voluntary” from the code suggests a stricter approach compared to its predecessor.
  • Focus on Transparency: Provisions like mandatory expenditure disclosure for conferences organized by pharma companies could increase transparency.
  • Addressing Travel & Hospitality: Discouraging pharma-funded travel and hospitality for doctors might reduce undue influence.
  • Potential for Improved Ethics: A well-enforced UCPMP could lead to a more ethical environment where marketing focuses on the merits of drugs rather than lavish incentives.

False Dawn:

  • Missing Teeth: The lack of clear penalties beyond industry association removal for pharma companies raises concerns about enforcement.
  • Rollback of NMC Code: The NMC’s stricter code for doctors with potential financial penalties was rolled back due to industry pressure. This weakens the overall impact.
  • Ambiguity on Non-Member Companies: The code’s effectiveness might be limited if pharmaceutical companies outside industry associations are not held accountable.
  • Uncertain Implementation: The success of UCPMP hinges on robust implementation and a clear mechanism to address violations.

Conclusion:

From the above perspective, the true impact of UCPMP 2024 remains to be seen. While it has positive intentions, its effectiveness depends on stricter enforcement mechanisms, penalizing violations, and ensuring all companies are held accountable. Only time will tell if UCPMP 2024 ushers in a new era of ethical practices or remains a symbolic but unenforced reform.

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

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

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.

 

Effective Change Management – The Magic Wand For Business Success And Sustainability

Change – just as it’s an integral part of our life, so is for any business, including pharmaceutical or healthcare. Interestingly, the phase of transition of such changes isn’t always slow and gradual. In many cases, especially for business, or for a lifestyle too, these transitions could also be faster and disruptive.

The speed of many such changes is now driven by rapidly evolving technology. Or these could often be triggered by some unanticipated event, like the Covid-19 pandemic that we all experienced, very recently. Such changes may impact people working in different functions, in different ways. Which is why, organizations need to be all-time ready, with a robust process in place – known as Change Management.

In this article, I shall focus on the relevance of putting in place a well-validated system driven Change Management process within, especially, the Indian pharmaceutical organizations. Let me start with my understanding on what is the Change Management, so that all of us be on the same page in this regard. 

To be on the same page on what is Change Management:

There are several definitions of the change management process expressed differently, but it’s core concept remains unchanged. One such illustration comes from The TechTarget network. It says:“Change management is a systematic approach to dealing with the transition or transformation of an organization’s goals, processes, or technologies. The purpose of change management is to implement strategies for effecting change, controlling change, and helping people to adapt to change.”

Why many pharma majors are considering it now, more than ever before:

Being amid a technological revolution, encompassing almost all aspects of life and then in the post-pandemic area, change is being expected as a way of life and business, more than ever in the past. Although pharma industry a late learner - and is also traditionally late to change – these can’t be now pushed to the back burner, any longer, as was happening in the pre-pandemic era.

‘Change Management’ can’t be pushed to the back burner, any longer:

This process has now attracted a sense of urgency for many pharma players, as we read and look around. Several big companies have already started addressing the leadership challenges to manage and leverage the evolving changes, as I wrote in my article of October 3, 2022, in this blog.

To be in sync with both customers and employee expectations on an ongoing basis, the change management process in an organization has assumed a priority. User friendly state of the art technology is facilitating to effectively address the growing intricacies of today’s field staff role by infusing leadership mindset change in the organizational culture. Emphasizing this point in my article on July 19, 2021, I underscored that such change should necessarily reflect the company’s vision for the future, unambiguously.

Most companies have changed over a period of time in varying degree:

Most companies have changed over a period of time. Nonetheless, today’s need, pace and the process of change demand a data science based customized approach. The good news is several pharma majors have also started feeling that they require not just to change with time, but also need to put more data science based cerebral input to fathom why and how it changed to be more effective in the future.

An insightful understanding is essential to put in place and kick start a right change management process. To give a sense of it, let me cite a contemporary example of one of the successful global pharma majors – GSK. This case study was prepared by the Project Management Institute.

Achievement of a key milestone could make all the difference:

When GSK initiated this process in 2009, the organization realized that an important milestone in the implementation of the company’s change initiative must be to gain the trust and belief of leadership—many of whom were neutral or cynical about it.

To achieve this goal a custom made ‘Accelerating Delivery and Performance (ADP) program; was found to be quite effective for the company. It delivered both hard business benefits as well as softer organizational development benefits. This approach allowed the team to gain the attention of those leaders who wanted both.

Five principles formed the bedrock of the ADP approach:

The following ADP principles are time-tested, contemporary, and several of these were practiced by GSK in their change management process when it started in 2009.

  • Changes should begin with the initiator of change and focusing on greater customer satisfaction.
  • Active support of all stakeholders in the process of change is critical.
  • Include all staff who will be impacted by the change – while defining, explaining, and ensuring accountability and continuously measuring the time bound shared goals, especially the business and financial ones.
  • Make sure they all share ownership for the outcome of change, through seamless teamwork.
  • Make a pilot study before pan organization implementation.

The change management process continues:

That the change management process needs to be ongoing even for successful drug majors – such as GSK, is particularly evident from their Press Release on June 23, 2021.

The communique giving details of the organization’s strategic and other transformation pathways, also highlighted, “New GSK to deliver step-change in growth and performance over the next ten years driven by high-quality Vaccines and Specialty Medicines portfolio and late-stage pipeline.” 

Specific areas of change, as the pandemic wanes:

There are several studies in this area, such as the one published in the Growth Faculty Learn, published on February 07, 2023. Let me paraphrase its summary as follows:

  • Although the pace of change in different businesses may vary but will certainly keep changing. The leaders should, therefore, act proactively to lead their teams through a well validated change management process to gain a competitive edge.
  • Full preparedness for the change and garnering change management skills before the process begins are critical.
  • Advance planning for employee wellbeing, well structured individual and collective communication strategy, deciding on specifics of a hybrid work culture – all based on data-science, are of great importance.
  • To ensure the effectiveness of the change management process a positive workplace environment is a must, which will stand on five pillars - Trustworthiness, Empathy, Genuineness, Self-awareness, and a Learning mindset.

Thus, it’s high time for all to realize that the pharma business ball game is now changing fast for all, creating an urgent need to focus on the critical areas of change.

Conclusion:

It now boils down to an important point, which was also echoed in an article on this area published in the Pharma IQ on November 23, 2022. It underscored just as any living being keeps moving on the pathway of change, pharma and healthcare industry should proactively follow a similar path.

External environmental factors would play a catalytic role to accelerate the speed of change. These include fast evolving consumer friendly digital applications and health apps - newer, better, and more targeted drugs and treatment processes, or even unprecedented disruptions of lives and livelihoods, just what we all have recently experienced.

A study published in the Pharma Marketing Network on October 27, 2021, also reiterated that the main goal of any change management approach is to foster support of all concerned that leads to good outcomes within an organization. It found that an effective way to implement a change is by engaging and inspiring employees to adopt new (and improved) ways of working.

Against the above backdrop, putting a structured change management process in place by Indian pharma players, I reckon, is now essential. This approach seems to be a Magic Wand, as it were, for ongoing business success and sustainability in today’s rapidly evolving paradigm.

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.

 

China Coronavirus And API Sourcing – A Threat… Or An Opportunity For India?

‘2015 – Year of Active Pharmaceutical Ingredients’ (API), announced the Government of India by a Press Release on February 25, 2015. This came after ascertaining that over-dependence on imports of bulk drugs or API, especially from China, is detrimental to India’s health interest. This decision was also in sync with the freshly announced, and well-publicized government objective regarding ‘Make in India’.

Two years down the line, on July 15, 2017, eHEALTH publication also deliberated on this issue in an article – ‘Why over dependence on APIs imported from China is harmful for India?’ It reiterated, India has proven capabilities in the generic drug formulations, but over dependence on China for sourcing – 70-75 per cent of APIs does not augur well for the Indian pharmaceutical sector. Because, as any interruption in supply from China can badly impact the sector, jeopardizing the health of millions of people, not just in India, but across the world, as well.

The reason for Indian drug formulation makers depending on China-supplied APIs, is mainly for its low cost, and not for any technological other reason, the article said. Regardless of the India’s announcement – ‘2015 as the year of API’, the API industry continued to struggle without much tangible support. Despite a lot of decisions still being in the pipeline, let me hasten to add, some inconclusive signs of early recovery have been captured in this space by some recent studies.

With the outbreak of the recent ‘coronavirus’ menace, the moment of truth has arrived in the country. On the one hand, it is posing a threat to the country’s API sourcing, on the other it could throw open a door of opportunity for Indian API manufacturers, as the Chinese API prices would start climbing up. But the question is, in which way it would evolve? In this article, I shall focus on this aspect of the new coronavirus menace, starting with a brief description of the background.

China coronavirus – when the alarm bell rang: 

According to the World Health Organization (WHO), on December 31, 2019, it was alerted to several cases of pneumonia in Wuhan City, Hubei Province of China. The virus did not match any other known virus, raising a great concern. No one knows how it affects people who are sick with it – how they can be treated, and what the countries can do to respond. One week later, on 7 January, Chinese authorities confirmed that they had identified a new virus.

What it does?

This new virus is a coronavirus, which is a large family of viruses that cause illnesses ranging from the common cold to more severe diseases, such as Severe Acute Respiratory Syndrome, such as SARS and MERS.

Since the virus, reportedly was first detected in Wuhan in people who had visited a local seafood and animal market, it is likely to have transmitted from an animal to humans. Nevertheless, several known coronaviruses are known to be circulating in animals that have not yet infected humans. The new coronavirus has been named novel coronavirus (2019-nCoV) and is the seventh coronavirus known to affect humans.

W.H.O has been working with Chinese authorities and global experts to learn more about it. However, because this is a coronavirus, which usually causes respiratory illness, the world body has circulated advice to people on how to protect themselves and those around them from getting the disease.

The damage, thus far:

Bloomberg on February 02, 2020 reported the death toll from the coronavirus outbreak has risen to 305, with 14,555 confirmed cases worldwide.  The first death outside of China took place in the Philippines on February 01. Alarmingly, 2019-nCoV infections have also spread to at least 15 other countries. These numbers keep increasing.

Nearer home, India, on January 30, 2020, also announced its first case. “One positive case of Novel Coronavirus – a student studying in Wuhan University — has been reported from Kerala,” said a statement released by the Health Ministry. On February 02, 2020, Reuters reported the second case of coronavirus in Kerala.

This scenario prompted the World Health Organization (WHO) to meet again on the last Thursday and declare the new coronavirus an international public health emergency.

The impact on the pharma industry:

Responding to the criticality of this situation, health authorities across the world are trying to put in place effective ways to overcome this crisis. In the healthcare space, medical scientists are ‘racing to develop a vaccine to protect people from the virus.’ One lab in California, reportedly. has plans for a potential vaccine to enter human trials by June or July this year.

Alongside, many are wondering about the looming threat that it poses on the API sourcing from China by the global pharmaceutical industry, including India. However, as I said earlier, some Indian experts, are also sensing an opportunity for country’s API manufacturers to fill the possible void, as it gets created.

API sourcing concern:

An exclusive survey conducted by Kemiex, titled ‘Coronavirus impact analysis for APIs, feed and food additives,’ among 97 life sciences professionals, published by them on January 20, 2020, reports some interesting findings. Some of the key ones are, as follows:

  • 85 percent experts foresee API and other ingredient supply disruptions, with 35 percent expecting a high and 50 percent envisaging a low impact.
  • Orders planned for the 1st quarter with delivery in 2nd quarter are expected to be mostly affected, while disruptions might continue a quarter. Only a minority believes the disruptions will last until year end or beyond 2020.
  • The biggest impact is expected from extended Chinese New Year holidays and delayed production start.
  • A first impact analysis based on preliminary information shows that only selected products such as amino acids (taurine…), certain vitamins and other APIs and additives could be affected.
  • European and other suppliers report readiness and stocks to secure delivery to end users during interruptions in China, or some of its districts. respectively.

However, other reports also underscore, with the proliferation of the new coronavirus the incidences of confirmed infection with clear symptoms and deaths are also expected to increase. This may lead the Chinese government to extend lock down several commercially important parts of the country. Which, in turn, could impact, among others, manufacturing and shipments of API and pharma ingredients for several months.

Some green shoots are now visible in India?

Quoting a JM Financial analysis, some media reports predicted, a worsening coronavirus crisis may benefit Indian API manufacturers, as it observed some green shoots in the Indian API manufacturing space. Analyzing the stocks of six local API manufacturers – Galaxy Surfactants Ltd., Fine Organic Industries Ltd., Navin Fluorine International Ltd., SRF Ltd., PI Industries Ltd. and UPL Ltd., it found that the stocks of these companies have beaten the market trend in recent years. They observed, the robust growth of these companies was fueled by end-user industries, and exports to China – which has closed many chemical facilities on environmental concerns.

Moreover, the increase in overall API demand – caused by shortages triggered by a serious disruption of API production in China’s Hubei province, and restriction of movement within China, is likely to drive the prices up with the spread of the epidemic. The cumulative impact of all this, would possibly help the Indian bulk drug manufacturers, significantly, helping India to tide over the API sourcing crisis.

Conclusion:

‘Scientists are racing to develop a coronavirus vaccine, but it could take years to reach the market,’ as media reports highlight. Meanwhile, researchers are, reportedly, also looking at ways of quickly repurposing existing antiviral drugs to see whether any might work against the new coronavirus.

The serious health menace caused by the new coronavirus that prompted the W.H.O to signal it as a global emergency, has also raised a serious concern on API sourcing. This is because, around 80 percent of the API used by drug formulation manufacturers is sourced from China.

Looking only at this aspect of the issue, and also from the Indian perspective, the point to ponder – is it all threat? Or a veiled opportunity worth cashing-on to neutralize, at least, a part of the API sourcing threat?

Against the backdrop of the Indian Government’s announcements, such as, ‘2015 – Year of Active Pharmaceutical Ingredients’ (API), alongside the well-publicized ‘Make in India’ campaign, and some recently reported green shoots in this area – the expectation of an ‘opportunity in waiting’, could well be a reality. Who knows? But, a lurking apprehension still lingers!

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.

Pharma Policy Execution Gap Limits Access To Affordable Medicines?

“The cost of new drugs is putting increasing pressure on people in both rich and poor countries”- was eloquently expressed in an article, titled “Why do new medicines cost so much, and what can we do about it?”. This was published by “The Guardian” on April 09, 2018.

Almost synchronically, expressing concern on this issue, the World Health Organization (W.H.O) advised the world leaders ‘to take bold new approaches’ for increasing access to medicines for all. A UN high-level panel on ‘access to medicines’ spent almost a year deliberating over related issues. The panel members were from pharma companies, as well as civil society and academics. The final report coming in September, backed de-linkage of the costs of R&D from the eventual price of the drug. Notably, the author who is also the health editor of the above publication, feels that any positive outcome in this direction is unlikely to materialize soon.

The majority of big pharma constituents, with the possible exception of GSK, whose then chief executive Sir Andrew Witty was unenthusiastic about the UN report. Probably because, it supported governments’ right to invoke ‘a get-out’ from the World Trade Organization’s TRIPS agreement. This is to bypass drug patents and make cheaper versions of the respective generic equivalents, in the interests of public health, in accordance with the 2001 Doha declaration. However, the author is hopeful that, “as happened with AIDS, each new crisis over access to medicines – whether concerning a common liver disease or a rare cancer, and particularly over the antibiotics that are under threat and vital to all our lives – is likely to put pressure on companies to find ways to bring the costs of medicines down.”

Stakeholder pressure for increasing access to medicines continues. Even in smaller developed countries, such as Switzerland, a section of the public demands that “Swiss authorities must act to make lifesaving drugs more affordable by introducing compulsory licensing.” Or, one can now see reports saying,“Irish patients are being denied access to nine drugs that are widely available across Europe, largely, on cost grounds.”

Nevertheless, regardless of mounting pressure for drawing a reasonable symmetry between cost of, especially new drugs and their improved access to patients, ongoing status-quo continues. In this article, I shall dwell on this concern from the Indian perspective, focusing on an agonizingly stark implementation-gap related to the current Indian pharma pricing policy.

Under pressure, pharma now recognizes the need for affordable drugs:

Coming under intense pressure of patients and other stakeholders, even the largest trade association of Big Pharma has recently changed its stance on this issue, though clearly sharking any responsibility for the same. It just recognized the need for affordable medicines for improved patient access to treatments by saying: “Too often patients have to fight to access breakthrough medicines that are revolutionizing how we fight disease.” It also accepted the fact that “many Americans are struggling to afford their medicines.”

“We can improve patient access and affordability by moving toward a system that prioritizes results for patients. Biopharmaceutical companies are working with insurers to develop innovative and flexible ways to pay for medicines that focus on results, lower out-of-pocket costs and enable patients to access the right treatments the first time” – it added.

What it really means: 

What it really means ‘treatment outcomes-based drug pricing’ or ‘value-based drug pricing (VBP)’. In other words, a situation where drug prices are set in line with their real and demonstrated clinical and economic value to patients, against other available products. This model will also ensure that patients’ money doesn’t get wasted from drugs that aren’t effective on them. The VBP model is, thus, significantly different from product pricing, based on ‘undisclosed’ cost of ongoing innovation for new drugs.

Is this Big Pharma’s new way to change optics?

The intent for imbibing VBP, as expressed by the above pharma association, throws open the door for discussion of its core intent. Is the intention real, or another Big Pharma way of changing general optics on the sensitive issue of new drug pricing? This doubt creeps in from the findings of some important studies on this issue. One such is an interesting paper, titled “Pricing for Survival” from KPMG. The analysis highlighted very limited application of VBP concept, and also why it is not yet viable – despite the hype being created around it.

According to KPMG, “there were 25 drugs engaged in various types of VBP with payers in the fragmented United States market as of September 2017. The problem is, these models appear to be limited in applicability to disease states with more standardized protocols and dominated by drug therapies with single indications – notably osteoporosis, diabetes and hepatitis C.” To date, VBP models seem to be facing several constraints, such as it is appealing mostly to payers that are fully integrated with healthcare delivery i.e., closed-loop payer-provider health systems or integrated delivery networks.

“The takeaway is, when it comes to specialty and orphan drugs, outcomes-based pricing simply faces too many barriers at present” – the article elaborated. Be that as it may, let me now explore the relevance of VBP in India.

Any relevance of VBP in India?

VBP has been tried in a health care environment where payers and drug companies are two critical players for access to affordable medicines, as we see in the KPMG study. Under any value-based pricing agreements for pharmaceuticals, both payers and pharma companies agree to link payment for a medicine to the value achieved, rather than volume.

Whereas, in the Indian healthcare scenario, as we are experiencing today, payers are mostly individuals.  Despite various well-publicized health schemes, expenditure on health, including drugs, remains by and large ‘out of pocket (OoP)’ – for a large Indian population. Hence, copying western framework for implementation VBP in India, would call for scores of ‘pharma – individual payer agreements.’ This would be a daunting task, if not impractical, to even try it out.

In this context, let me touch upon the Ayushman Bharat scheme that was launched by the Prime Minister on September 23, 2018, but just in one of the 29 states of India – Jharkhand. If, or as and when it will cover the entire country, the scheme is expected to bring 107.4 million families and more than 550 million people under health insurance coverage. However, the work seems to be still in progress.

There are three financing models for this scheme – insurance model, trust model and hybrid model – and the 19 states that have come on board for the scheme’s implementation in the country, have chosen a trust model, according to the Union Health Minister. The minister also reiterated: “Things are still unfolding. Only when the letters reach the beneficiaries will they understand and react.”

Nevertheless, the Union Health Minister himself, just like his counterparts in the previous governments, exhibited confidence that the country is “moving towards universal health cover with Ayushman Bharat scheme,” – as was the headline of the above media report.

Going by the past and current outcomes of several such government schemes in the country, and what the minister himself articulated on September 17, 2018, a large section of the Indian population still remains  apprehensive on the fast pan-India rollout and overall success of this ambitious health scheme. Hence, at this stage, I reckon, it may not be relevant to discuss the application of VBP model on Ayushman Bharat project. I wrote about such apprehensions in this Blog on June 18, 2018.

Having said that, VBP still remains relevant when we look at the government’s intent captured in the National Pharmaceutical Pricing Policy (NPPP) 2012,’ as I shall discuss below.

VBP and the policy implementation gap:

For making the point clearer, let me keep the Ayushman Bharat scheme aside because of its associated uncertainties. Even in the current health care environment of high OoP expenditure on drugs, especially on high priced new drugs, if one tries to make use of the VBP model, it is very much possible.

This is because, the National Pharmaceutical Pricing Policy 2012, under point 4 (XV) on ‘Patented Drugs, categorically states:  “There is a separate Committee constituted by the Government order dated February 01, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented drugs would be taken based on the recommendations of the Committee.”

Curiously, even 6 years down the line, no meaningful decision has been taken on patented drug pricing in India by the successive governments. As I wrote in this Blog on December 12, 2016, Price Negotiation For Patented Drugs: Still A Policy Paralysis.

Parliamentary Standing Committee intervenes:

Six years after the constitution of the committee by the Department of Pharmaceutical (DoP), the long-awaited report was eventually submitted with a vague formula for pricing patented drugs in India. Intriguingly,the issue remained as such, until the Parliamentary Standing Committee’s August 2016 report was placed before the parliament. It strongly criticized the DoP’s efforts to recommend measures in regulating prices of life-saving patented drugs, despite government assurances for the same.

On September 23, 2016, media reported: “Upbraided by the parliamentary standing committee for its gross negligence and lackadaisical attitude, the department of pharmaceuticals has set about seeking suggestions from different ministries on price regulation of patented drugs.”

According to reports, a new inter-ministerial committee was formed thereafter, under the chairmanship of one of the Joint Secretaries of the DoP to suggest a new mechanism to fix prices of patented drugs in the country.
The other members of the committee are Joint Secretary – Department of Industrial Policy and Promotion (DIPP); Joint Secretary – Ministry of Health and Family Welfare; and Member Secretary – National Pharmaceutical Pricing Authority (NPPA). But, the saga continues – at the cost of patients’ health interest.

Conclusion:

As it appears, there still lies a clear opportunity for Indian drug pricing policy makers introduce VBP concept for patented drugs in the country. Following this model, the prices of new and innovative drugs under patents can be set in line with their real and demonstrated clinical and economic value to patients, over the available existing products. Health Technology Assessment (HTA), for example, could be an effective tool in this process.

Additionally, the VBP model could also minimize, if not eliminate the risk of patients paying a high a price for new drugs coming through incremental innovation, adding too little clinical and economic value over existing drugs. There may, of course, be some teething trouble or even important issues in arriving at consensus on value-metrics for VBP. But, this can be sorted out through meaningful engagement with concerned parties.

Strikingly, even after 6 years since the NPPP 2012 was announced, nothing tangible has been made known to stakeholders on the execution of ‘patented drug pricing policy’ in India. An avoidable policy execution gap continues, limiting access to affordable new medicines to a vast majority of the Indian population, even today.

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 Price Control And National Health Security

‘Without Providing Affordable Medicines, There Can’t be Health Security’, said the Union Minister of Chemicals and Fertilizers of India, as reported on September 22, 2017. Although, the Minister made this remark while discussing Government price control on cardiac stents in India, let me dwell on the subject based on the above news headline by asking: Is drug price control improving access to medicines for greater ‘Health Security’ of the country?

It’s no rocket science to understand that making affordable drugs ‘available’ in requisite quantity for all, is essential, basically, for improving ‘access’ to medicines. Nevertheless, the mere availability of drugs is no guarantee for their improving access to all.

If we take a closer look at the well-articulated key objectives of the Ministry of Chemicals and Fertilizers, under which both the Department of Pharmaceutical (DoP) and the National Pharmaceutical Pricing Authority (NPPA) belong, this dichotomy will be easier to fathom.

The key objective of the ‘National Pharmaceutical Pricing Policy: 2012’, which is operational today, reads as: “To put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of the industry, thereby meeting the goals of employment and shared economic well-being for all. The reasons are further elaborated later in the Policy Document.”

Similarly, according to the NPPA, one of the key objectives of drug price control in India is to ensure abundant availability, at reasonable prices of essential and life-saving and prophylactic medicines of good quality. Hence, the current key focus of the DoP and NPPA, on paper, does not go beyond making ‘affordable drugs available for all.”

Thus, the crucial point to ponder: Is ongoing drug price control, improving even availability of medicines for all to attain greater ‘health security’ of the country, as the Union Minister underscores?

A course correction without flagging the new course:

The Draft Pharma Policy 2017 makes an important course correction to address this critical issue. It expresses its objective in this important area slightly differently, by adding the word ‘accessible’, as: “Making essential drugs ‘accessible’ at ‘affordable prices’ to the common masses.”

Intriguingly, the draft remains mute, when it boils down to answering the fundamental question, how would this new policy improve access to affordable drugs for the common masses, without having any jurisdiction to improving access to overall health care? That turf, unquestionably, belongs to the Ministry of Health. Thus, I reckon, achieving this modified goal, in its totality, is no more than a rhetoric.

Would better availability guarantee greater patient access to drugs?

As things stand today, it is quite unlikely to happen. The broad process of improving access to health care in a holistic way, is enshrined in the  National Health Policy 2017, which is already in place. It assures the nation of progressively achieving ‘Universal Health Coverage (UHC)’. It outlines measures to improve the availability, access and affordability for quality secondary and tertiary care services, with significant reduction in ‘out of pocket expenditure’ on health care. The policy also emphasizes that this process would considerably reduce the proportion of households experiencing catastrophic health expenditures, and consequent impoverishment.

The silo mentality won’t work:

Although, the Ministry of Health is primarily responsible for meeting universal access to health care, which includes drugs, the Ministry of Chemicals and Fertilizers too, shoulders a crucial responsibility in this area. Thus, attaining the Health and Pharma policy goals – individually, collectively and meaningfully, both these Ministries need to work closely together, along with the State Governments, in the true spirit of cooperative federalism. The silo mentality has not worked and won’t work, ever, to meet health aspirations of the people.

Access to health care – a prerequisite to improving access to affordable drugs:

As I see it, access to health care for all is a prerequisite to improving access to affordable drugs for country’s ‘health security’. Without providing access to requisite health care, making affordable drugs available for all, does not make much sense, if at all. This is because, patients will buy or get medicines only when a medical or paramedical professional will advise and prescribe them what to buy while treating any particular ailment.

Is the key pharma policy goal anywhere near its target?

Be that as it may, let me now try to gauge whether even the current key goal of the pharma policy to make an increasing quantity of affordable drugs available to more number of the population is anywhere near its target or not.

Capturing the impact of the present pharma policy on the ‘health’ of Indian pharma industry, the Annual Report 2016-17 of the Department of Pharmaceuticals (DoP) acknowledges that owing to the Government’s efforts to make medicines affordable, the domestic Pharma market witnessed a slowdown in the ongoing financial year. The industry registered a decline in growth of 7.4 percent over the corresponding figure for 2014 -15, with a similar aftermath in its financial performance.

Interestingly, a Press Release of Ministry of Chemicals and Fertilizers of September 27, 2016 claims that ‘ceiling prices’ of 464 formulations fixed after announcement of NLEM, 2015 and Revised Schedule-I, resulted in savings of Rs 2288 crore for consumers. Let me also add that a September 22, 2017 tweet of the same Union Minister gives a much higher number in this regard, which includes cardiac stents, though.

Fair enough, in that increasing patient access to affordable drugs ought to get reflected in the reasonable incremental volume growth of the Indian Pharmaceutical Market (IPM), at least, of those products, which feature in the National List of Essential Medicines (NLEM)? Contrary to this expectation, according to an article published by ‘Pharmabiz’ website on the CPhI India Special supplement in December 2016, ‘over the past 3 years (FY 2013 – FY 2016), the IPM has grown at a CAGR of ~ 11%, much lower than its historical average growth rate of 15%.’

Thus, both the private retail audit data, and also the submission of the DoP clearly indicate that this has not happened, as a desired outcome of drug price control.

Drug price regulations aren’t irrelevant either:

My above argument doesn’t also mean that drug price control, or stringent price monitoring, or tough price negotiation – in whatever way one may call it, is of no use; even where Universal Health Care (UHC) is up and running. This is regardless of whether this universal care is insurance driven, as in the United States, or state funded, as in the United Kingdom. As I said before, access to health care for all is a prerequisite to improving access to affordable drugs. I stressed this point briefly in one of my recent articles published in this blog, while focusing on another important development.

Drug price regulation in the UHC countries:

In case of insurance driven UHC, insurance companies or related payers, or even the regulators, mostly enforce stringent control on drug prices, as is currently happening in the United States. This fact is vindicated by a May 29, 2017 report that indicates: “The pharma industry, under the constant glare of the US drug regulator, has to contend now with pricing pressures in the American market.” The report further highlighted: “From Sun Pharma and Lupin to Glenmark, Dr. Reddy’s and the others, price erosion in generic drugs has been a common anguish as they declared their results for the fourth quarter ended March 31. For some of these companies, more than 40 per cent of their revenues come from the US market. The developments came at a time new launches in the US – at least for some of them – have taken a hit because of regulatory action. Pricing pressure in generics is not new, but this has exacerbated in recent times, with experts warning of further deterioration.”

Similarly, where the UHC is funded by the State, such as in the United Kingdom, prices of branded pharmaceuticals supplied to the National Health Service (NHS), are controlled either by the ‘Pharmaceutical Price Regulation Scheme (PPRS)’ or by the ‘Health Service Branded Medicines Regulations 2008’. The situation is no different virtually in the entire Europe.

Moreover, in Japan, where UHC functions so immaculately, the regulatory officials of the country announced in December, as reported on 7th March 2017, the Government plans to review drug prices more frequently –  annually for all therapies and quarterly for the newest, and most expensive ones that are used widely. Over recent months, the price of Opdivo, a blockbuster cancer drug from Bristol-Myers Squibb Co. and Japan’s Ono Pharmaceutical Co., was halved in Japan following a 32 percent cut in April for Gilead Sciences Inc.’s hepatitis cure Sovaldi, the report said.

In addition, an OECD report dated January 16, 2017 observes: “The proliferation of high-cost medicines and rising drug prices are increasing pressures on public health spending and calling into question the pharmaceutical industry’s pricing strategies. Governments need to work with the industry and regulators to define a new approach to the development and use of new health technologies that encourages innovation while also delivering more affordable and value for money treatments.”

Hence, drug price regulations aren’t irrelevant, either in India or even in countries with a robust UHC system in place, not just yet.

The rationale behind drug price control in UHC countries and India:

The major difference in the rationale of drug price control between the countries with UHC and others, such as India is as follows:

  • UHC countries extend health coverage between 80 to 100 percent of the population, on an average, with a very low percentage of ‘out of pocket expenses’ on drugs. Hence, the Government and other payers want to keep their own cost of drugs within a reasonable limit with drug price control, though its methodology varies from country to country.
  • On the other hand, in countries, such as India, where UHC is not available, over 70 percent of the population incur ‘out of pocket’ expenses on health care – and over 60 percent of which is spent on drugs. Hence, the Government intends to ensure a significant reduction in ‘out of pocket expenditure’ towards medicines, by trying to make more affordable drugs available to many through drug price control.

Conclusion:

All health care related policy measures of the Government are important for the nation. As I know, the related discussion papers are circulated by the Government only after several informal and ongoing discussions on the subject with the stakeholders, and considering other feedbacks received in that process.

Despite this general mechanism, several points of draft proposals, or even the final policy, are often not liked by all, triggering a raging debate and inviting stringent criticisms, including disagreement from other ministries. For example, according to reports: “Even as Prime Minister Narendra Modi announced the government’s intention to ensure access to affordable medicines, the government policy think tank NITI Aayog seems to be pushing for greater deregulation of drug prices and to disempower India’s drug price regulator.” Just as many others, I also often participate in such debates.

That said, improving not just availability, but in tandem with greater access to affordable drugs, would play a key role to foster overall ‘Health Security’ of the country. Drug price control or its equivalent measures, alone, does not improve access to affordable drugs, except shaving off significant revenue and profit of the pharma companies. Whether the appropriate terminology in this case would be ‘profit’ or ‘profiteering’, is part of a separate debate, altogether.

Neither, impeccable sets of pharma and health policies, implemented in-silo by the two different ministries, will help achieve this goal. As is well researched, an excellent policy with shoddy or improper implementation, fetches far worse outcome than an average policy when implemented well, and in close coordination with other policies having common goals. This holds good even while striving for a robust ‘Health Security’ for the country.

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.