Tag Archives: Availability

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.

Exploring An Exit To India’s Covid Management Maze

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‘India’s Covid-19 Crisis is Spiraling Out of Control. It Didn’t Have to Be This Way,’ was the headline of the lead article, published in The Time with the cover page ‘India in Crisis.’ All Indians also believe the same, as the current reality is shown virtually live in TV news channels daily, with experts commenting on the same.

Ironically, many in the country’s leadership still remain in a ‘denial mode’, even when the country records globally highest number, ever – over 402,110 daily new Covid-19 cases with 3,688 daily deaths, on April 30, 2021. One can also gauge how grim the situation is from the example of the US alert to its citizens in India. It says, ‘access to medical care is becoming severely limited because of a surge in Covid-19 infections and those wishing to leave the country should take advantage of available commercial transportation options.’

Notably, when most Indians, including the President of India, were taking pride in the country’s ‘Aatma-Nirbhar Bharat Abhiyan,’ especially in the Covid-19 vaccine area, during the pandemic, the stark reality appeared to be quite different. Pandemic demonstrated that each country is, in fact, interdependent. One may not acknowledge it in the days of hubris. However, when a crisis, like Covid 2.0 strikes the nation hard and interestingly – not unannounced, as many experts write, the reality dawns. This is also a reality that India as a nation could not adequately prepare itself for Covid 2.0 onslaught, even over a yearlong Covid 1.0 pandemic.

Nonetheless, India now needs global help, almost for everything – in the prevailing calamity – Oxygen, drugs like, Remdesivir – and vaccines, besides many others. Quite expectedly, witnessing the Covid 2.0 tragedy in India ‘Aid (also) pours in from the world to counter India’s Covid-19 second wave.’ Alongside, along with Indian media, even foreign media reports, ‘Bodies piling up at crematoriums: Record death toll may hide extent of India’s COVID-19 crisis.’

Amid Covid crisis, most countries in the world, including the United Kingdom, the United States,Israel and even India’s neighboring country - Bhutan focused on the mass Covid vaccination drive – at a blistering pace, to create a herd immunity. In this article, I shall explore the drivers and barriers for India to achieve a similar goal, soon.

Current developments with vaccine in India:

The latest development is – after a protracted hesitation, the Government of India opened ‘Covid-19 vaccination for all above 18 years of age,’ effective May 01, 2021. However, not so good news is, this happened at a time when the country is experiencing a Covid-19 vaccine shortage even for all adults above 45 years of age. Believing that government has taken this decision without enough advance preparation, experts warn, India is likely to face extreme Covid vaccine shortage from May 1.

They express concern: ‘India is running out of vaccines just as the new wave of Covid-19 infections batters the country, complicating Prime Minister Narendra Modi’s plan to inoculate the nation’s workforce while threatening to drag out the world’s worst healthcare crisis.’

India rejected ‘emergency use’ of imported Pfizer and other vaccines, unlike other countries:

Some decisions by Indian vaccine expert panel also delayed more vaccine availability in the country for ‘emergency use,’ sooner. For example, Reuters reported on February 05, 2021, ‘Pfizer drops India vaccine application after regulator seeks local trial.’ The Company had applied to the DCGI for a waiver of a local trial for importing its mRNA vaccine in India.

Similarly, as reported on February 25, 2021, ‘Expert panel seeks safety data for Russia’s Sputnik V Covid-19 vaccine before emergency use nod,’ in India. Ironically, it was again rejected on April 01, 2021. However, facing the fierce Covid.2.0 wave Sputnik V vaccine is now being imported from Russia. Similarly, as reported on April 30, 2021, ‘Pfizer begins exporting U.S.-made COVID-19 vaccine to Mexico.’ Pfizer has already exported 10 million doses to Mexico.

In the quagmire of indecision, late decision and other non-life saving priorities are omnipresent:

Many Indian and overseas experts opined that valuable time was lost to have more vaccines in India, by now. This is because, amid a wrenching surge in infections and deaths, on April 14, 2021 – ultimately, India agreed to fast-track vaccine approvals for ‘emergency use,’ without local trial. These are now applicable to all those Covid vaccines that have already been authorized by ‘drug regulators in the US, UK, European Union and Japan or cleared by the WHO, without having to conduct a local bridging trial.

The above developments, I reckon, gave rise to two core issues in vaccinating the Indian population of above 18 years of age – at a ‘blistering pace,’ as happened or is happening in countries, like the UK or the US.

Whereas, for speedy mass vaccination wealthy governments took a quick decision to stock up on COVID-19 shots from Pfizer and Moderna Inc, because of their extremely high efficacy. More so, when safety concerns and production problems temporarily sidelined vaccines from AstraZeneca Plc and Johnson & Johnson.

Two core issues for a speedy vaccination process in India:

No domain experts in the world doubt that mass vaccination is India’s Covid-19 escape route from the prevailing health care massacre. However, arising out of the above developments, successful implementation of Covid vaccination process  on the ground, making it available and affordable to all, poses a giant challenge. Thus, to effectively address the two core issues, with the quality of speed that it deserves, finding answers to the following questions are critical:

  1. How to add speed to the vaccination process?
  2. How to avoid different pricing for the same vaccine for the Central Government, the State Governments and the Private Hospitals? This will give a choice to the population for speedy vaccination, removing many personal apprehensions involving the entire process.  

Let me give an example, each of the most recent quagmire related to each one of the above issues.

All vaccination centers in Mumbai were shut for three days for shortages:

Reuters reported on April 30, 2021 carrying a headline, ‘Indian states run out of COVID-19 vaccines; nationwide inoculation delayed.’ It added, several Indian states have run out of COVID-19 vaccines a day before a planned widening of a nationwide inoculation drive. Interestingly, quoting Indian authorities it elaborated: ‘All vaccination centers in India’s financial capital Mumbai were shut for three days starting Friday due to a shortage of vaccines, as the country posted another record daily rise in coronavirus cases.’ The same saga can be witnessed in the national capital of India. ‘Don’t queue up outside Covid-19 vaccination centers tomorrow, the stock will arrive in 1-2 days,’ urged the Chief Minister of Delhi.

The Government allowed Covishield and Covaxin price increase amid pandemic:

Covishield and Covaxin were being purchased by the central government at a price of Rs. 150 per/dose. While announcing Covid vaccination eligibility to all Indians above 18 years of age – despite vaccine shortages, the government allowed the two Indian vaccine manufacturers to increase the same vaccine prices – for direct supply to the state governments and private hospitals.

The manufacturers lapped up this decision and increased the vaccine prices by several times, amid catastrophic Covid 2.0 pandemic. For example, for state governments the Covishield price was raised to Rs.400/per dose and Rs.600/per dose – for Covaxin. However, facing severe criticism from all quarters the prices were revised to Rs 300 (Covishield) and Rs.400 (Covaxin). Interestingly, still the price increases were double or even more from the initial prices of Rs.150/per dose.  Interestingly, one manufacturer even boasted  this so called ‘price reduction’ from their initial humongous price increases, as a ‘philanthropic gesture’. Interesting indeed!

A hidden solution within Supreme Court questions to the Center:

While hearing a Suo Moto case in connection with the ongoing Covid 2.0 calamity in the country, the Supreme Court of India also took note of the difference in Covid vaccine prices for the Centre and the state governments. It observed Covid vaccine manufacturing is publicly funded, hence are public goods – these are ultimately meant for the people of India. At the same time, the apex court asked some of the following profound questions to the central government on Covid 2.0 management in the country:

  • Why is the center not following the national immunization program policy in its Covid-19 vaccination drive where the Centre will buy all vaccines from the manufacturers?
  • How much investment has the Centre made into the vaccine companies and given advances in the last year?
  • What has been the financial contribution by the Union govt in research etc. in the development of vaccines?
  • How will the Centre ensure registration for vaccines for illiterate people and those without internet access as registration through Co-Win is mandatory in the third phase of vaccination?
  • Will one state get priority access over another in getting the vaccines?
  • How will the Centre ensure equity by private vaccine manufacturers when it is buying only 50 percent of the doses?
  • Has the center considered invoking Section 92 of the patents act and issue compulsory licenses so that drugs can be manufactured while the royalty is sorted?
  • Why are we paying so much for this vaccine for which AstraZeneca has set at a far lower price to the US citizens?

One may possibly find a hidden solution to the question of invoking Section 92 of the Indian Patent Act (IPA 2005) to address some critical Covid vaccine related issues in India.

Is invoking section of IPA 2005 a near-term solution?

As many would know, Section 92 of the Indian Patents Act is a special provision enabling the Central Government to issue Compulsory Licenses for the manufacture of patented drugs in a public health emergency. Section 100 of the IPA enables the Central Government to use patented inventions for government purposes. Curiously, the Supreme Court of India has, reportedly, also observed: “This is an exact case where we should go for compulsory licensing. This is a situation of Public Health Emergency.”

Just to recap, on October 02, 2021, India and South Africa had proposed at the WTO about an IP waiver for Covid-19 drugs and vaccines that could help resolve the urgent issues of access and affordability to these products. It has also been reported: ‘Richer members of the World Trade Organization (WTO) blocked a push by over 80 developing countries on Wednesday to waive patent rights in an effort to boost production of COVID-19 vaccines for poor nations.’

Although, U.S. Trade Representative has recently met with Pfizer and AstraZeneca to discuss this proposed IP waiver for Covid vaccines and drugs, what stops India to invoke Section 92 and 100 of its own Patent Act even during this seemingly uncontrollable Covid 2.0 pandemic?

The April 06, 2021 article of the Observer Research Foundation aptly epitomized the need of the hour. It articulated: ‘As the pandemic continues to rage, countries collectively have to find innovative ways to not just increase the production of vaccines, but also ensure their timely distribution at affordable prices.” Such an initiative may encourage more manufacturers in India to manufacture enough Covid vaccine, facilitating speedy inoculation to Indians and at the same time the government can make its price affordable for all concerned.

Conclusion:

The question, therefore, arises: Is India’s exit to the Covid 2.0 maze now visible? But, before arriving at any possible conclusion in this regard, one may try to address, at least, the following two critical questions:

  • Can Covid vaccines be reverse-engineered by domestic pharma industry without inventors sharing ‘Know-How’?
  • Can the IP waiver by the WTO or invocation of section 92 and 100 of IPA 2005 by India, legally mandate vaccine developers, like AstraZeneca, Pfizer-BioNTech or Johnson & Johnson, to share know-how with others, if they do not want to do so?

The resolution of the above issues won’t happen in a jiffy – at this stage. It may take more time. So, I reckon, will be the search for a permanent exit to India’s Covid 2.0 management maze, to avoid a similar strike by Covid 3.0, if or as and when it will come. Thus, till all adult Indians get vaccinated, each one of us must comply with Covid appropriate behavior responsibly, to save ourselves, our families, neighborhood, and above all our own nation.

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.

 

 

New Digital Tools To Protect From Infection, Neutralize Covid-19

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There seems to be some light at the end of the dark tunnel of a serious biological threat that the world is passing through, since the nightmarish last seven months. The COVID-19 pandemic has spread to 213 countries and territories, and the number of new cases is continuously rising. According to reports, the severity of the situation has already re-shaped our society, more than ever before.

In tandem, reports are arriving from most countries, testifying the tremendous commitment of the governmental, scientific and clinical communities, to help local populations dealing with the pandemic. Scientists are still far from having a complete picture of the pathophysiology of this dangerous disease, including its long-term implications on individuals.

Amid this challenge, round the clock search for a life-saving and long-term pathway to outmatch the fast-spreading Covid-19, seems to be coming to fruition, soon. If everything materializes as expected, Covid-19 vaccines may be available by the end of this year or at the beginning of the next year. If it happens, this will be a record in the history of any vaccine development process, as the normal ‘mind to market’ period to deliver a scientifically proven, safe and effective vaccine is normally around 10 years. That said, there always exists a gap between the cup and the lip, as the saying goes.

No doubt, vaccines will be the best way to bring the new Coronavirus under a tight leash to help normalize life, restore livelihoods, and putting a nation’s economy back to the growth trajectory. The good news is, alongside this magic bullet, the power of technology is exploring other technological measures to keep the virus at bay, wherever possible. In this article, I shall focus on this interesting area.

Let me hasten to add, the value offerings of these devices can’t be compared with the long-term benefits that vaccines will offer in containing this global pandemic. Nevertheless, the questions still remain, when will a well-documented, safe, effective and affordable vaccine hit the market?

W.H.O expects to deliver 2 billion doses of vaccines by end 2021:

According to a News Release of July 15, 2020, by the World Trade Organization (W.H.O): ‘Seventy-five countries have submitted expressions of interest to protect their populations and those of other nations through joining the COVAX Facility, which aims to:

  • Accelerate the development and manufacture of COVID-19 vaccines.
  • Guarantee fair and equitable access for every country in the world.

The goal of COVAX is to deliver two billion doses of safe, effective vaccines that have passed regulatory approval and/or WHO pre-qualification, by the end of 2021. Besides W.H.O, other experts are also cautiously optimistic about the availability of Coronavirus vaccines ‘soon’. Here also the question may crop up: how soon is ‘soon’?

How soon is ‘soon’ – for sooner availability of Covid-19 vaccines?

Experts have opined, a vaccine would normally take years, if not decades, to develop. However, in this unprecedented global health crisis, researchers hope to achieve the same amount of work in only a few months, following the ‘fast track’ regulatory pathway. Let me give a sense of the prevailing buzz around the availability of some of these vaccines.

Going by what the Chief Executive Officer (CEO) of Serum Institute of India said about Oxford-AstraZeneca developed vaccine, many expect their availability by the end of the current year in India. The Company CEO, reportedly, said on July 22, 2020: “By November, we hope to launch the vaccine if the trials are positive and if the Drug Controller of India blesses it and says it is safe and effective.”

Further, on July 28, 2020, Moderna Inc. and Pfizer Inc. also launched two 30,000-subject trials of Covid-19 vaccines that could clear the way for regulatory approval and widespread use by the end of this year, as the companies announced. Notably, both vaccine candidates rely on a new technology that allows for faster development and manufacturing than traditional vaccine production methods, but does not have an extensive track record.

According to another report of July 30, 2020, Russia said, the world’s first COVID19 vaccine to be ready by August 12, 2020. The vaccine is being developed by Moscow’s Gamaleya Research Institute of Epidemiology and Microbiology.

India’s indigenous experimental Coronavirus covid19 vaccine candidate, developed by Bharat Biotech, is also undergoing phase 1 and Phase 2 trials at 12 sites spanning across India. The initial results are positive. Earlier, ICMR had announced its launch on August 15, 2020. However, specialists in this area feel, ‘the August 15 timeline seems totally unrealistic, if not entirely impossible.’

Be that as it may, most experts still think a vaccine is likely to become widely available by mid-2021, about 12-18 months after the new virus, known officially as Sars-CoV-2, first emerged. Bringing to the market a Covid-19 vaccine, no doubt, will be considered as a ‘huge scientific feat,’ but ‘there are no guarantees it will work’ for all. It’s also a point to ponder that ‘Coronaviruses already circulate in human beings. They cause common cold symptoms and we don’t have vaccines for any of them’ just yet, as the report highlights.

It’s, therefore, a clear possibility that a well-documented, safe and effective Covid-19 vaccine may not be available, at least, in the next 6 months. Moreover, access to an affordable Coronavirus vaccine by the global population will also not happen in a jiffy. In that case, it is encouraging to note that other cutting-edge technological initiatives are also moving ahead with a great speed, to bring the rapid transmission of the new Coronavirus under a tight leash.

Novel, non-medical tech initiatives to contain the Covid-19 spread:

As potentially lethal Covid-19 is overwhelming the world, besides search for new drugs, faster diagnosis to fight the infection – and most effective preventive measure – vaccines, several non-medical tech initiatives are also underway. Many of these are quietly heading forward in search of user-friendly solutions, not just to ‘take the pressure off overworked health care workers’, but also ‘to stop the spread of the disease.’ These are all running parallel to offer technology driven disease treatment-options during this global health crisis.

An interesting paper from the European Parliamentary Research Sevice (EPRS), also vindicates some critical developments in this area. It focuses on technology-based solutions for various pressing pandemic-related problems. Let me illustrate this point with one example each, in the areas of ‘taking the pressure off overworked health care workers’, and in ‘stopping the spread of the disease.’

Technology to ‘take the pressure off overworked health care workers’:

Even in India, one hears quite a lot about the hardship of overworked health care workers. Various unconventional ways were also prescribed for the nation to encourage them. Some of these aren’t inexpensive, either. From this perspective, one such application is robotics technology. It can be effectively used as an intelligent solution to reduce the risk of person-to-person transmission − especially in pandemic hotspots. As the above EPRS article highlighted, many countries are now deploying robots in other areas also to ‘take the pressure off overworked health care workers,’ such as:

  • To disinfect whole hospitals,
  • Decontaminate public and private sites,
  • Handle biohazardous waste,
  • Deliver food and medication to infected patients,
  • Taking patients ‘ temperatures and act as medical assistants.

For example, an Israeli-made AI-powered robot assistant is, reportedly, being used in hundreds of hospitals, medical centers, nursing homes, and corporate buildings in Asia. This is to help minimize human-to-human contact as millions of people take precautions due to the novel Coronavirus outbreak worldwide. By the way, Israel is now a good friend of India, too.

Technology ‘to stop the spread of the disease’:

On June 01, 2020, Science Daily reported, the researchers at Penn State, the University of Minnesota and two Japanese universities, have found that a personal, handheld device emitting high-intensity ultraviolet light to disinfect areas by killing the novel Coronavirus, is now feasible.

Another report of July 10, 2020 also brought to the fore that the researchers from the University of Houston have created a new air filter that virus tests at the Galveston National Laboratory found can kill 99.8 percent of COVID-19 instantly. The filter could be useful for killing COVID-19 in public places, such as, in airports and airplanes, in office buildings, schools and cruise ships, besides other closed spaces such as schools, hospitals and health care facilities. Thus, the ability of this “catch and kill” air filter to control the spread of the virus could be very useful for society,” confirmed another report.

On July 29, 2020, an Indian business news daily wrote, ‘Bengaluru-based Organization De Scalene has received clearance from the US Food and Drug Administration (USFDA) and the European Union to license and manufacture Scalene Hypercharge Corona Canon (Shycocan).’ The device disables the virus’ capability to infect, by flooding electrons in closed areas. It is claimed that Shycocan ‘has the ability to neutralize 99.9% of the Coronavirus that might be floating in the air in closed spaces.’

Although, it is not an alternative to medicines that can cure infected people or preventive vaccines, the device can be used to keep Covid-19 at bay, at least, till vaccines arrive. Thus, going by these developments, one gets a sense of various non-medical technological activities post Covid-19 pandemic outbreak. Especially about, how today’s technological whiz kids are working alongside the medical scientists to take the sting out of Covid-19 onslaught.

Conclusion:

The Lancet article – ‘Applications of digital technology in COVID-19 pandemic planning and response,’ published on June 29, 2020, also made similar observations. It said: ‘With high transmissibility and no effective vaccine or therapy, COVID-19 is now a global pandemic.’ In this scenario, to contain the spread of a highly transmissible virus, countries that have quickly deployed digital technologies in various critical areas to contain the spread of the infection, may emerge as front-runners in managing disease burden, the paper concluded.

As of August 02, 2020 morning, the recorded Coronavirus cases in India reached a staggering 1,751,919 with 37,403 deaths. Recent Sero-surveys also show COVID-19 peaks in the country is still far away. It is very likely that a vast majority of the population will survive the Covid-19 catastrophe, even if only the existing systems are followed. But, just surviving is neither the reason nor the purpose of life. What most people want today is finding out a comprehensive way for – ‘jaan bhi and jahan bhi’ (life also, the world also).

Understandably, on July 31, 2020, W.H.O has also reiterated: “The pandemic is a once-in-a-century health crisis, the effects of which will be felt for decades to come.” Under this backdrop, unleashing the potential of new non-medical digital tools, as illustrated above, seem to be of immense benefit – not just to protect many more people from the infection, but also to neutralize Covid-19 effectively, especially in India.

By: Tapan J. Ray

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

Covid-19 Drugs: Accessibility, Affordability And Availability

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Covid-19 continues refusing to unravel the key to neutralize its destructive power – for bringing human life and the socioeconomic fabric of a country back to the old normal again. Just as India, all other countries are, apparently, awaiting a ‘magic bullet’ to come, breaking the shackles of this labyrinth, so to speak.

General expectation is, all concerned will understand that coming out of the new Coronavirus maze, sooner, at any cost – is the only way to bring back life, livelihoods, social fabric and the national economy on to the rail, again. Consequently, every entity in the world would require making moderate sacrifices in this unprecedented endeavor.

Right at this time, accessibility, affordability and availability of emergency use Covid-19 drugs, for various reasons, are going beyond the reach of a large number of the population who need those the most. This is happening not just beyond the shores of India, but in the country, as well, perhaps much more than expected. Interestingly, the issue pertains more to Covid-10 repurposed older drugs, and not so much for vaccines – just yet, as I shall deliberate below.

In this article, I shall focus on this issue, hoping for a reversal of the current trend through active involvement of the both the drug company leadership, and also the national decision makers to safeguard public health interest. Interestingly, the drug pricing issue, mostly with repurposed older drugs, is both global and local. Thus, let me first dwell on the subject of drug price increases during this global public health emergency.

Drug price increases during a global public health emergency: 

According to the July 08, 2020 report of IHS Markit, prices of critical drugs are increasing at a time when they are needed the most, as the governments and individual patients potentially struggle to pay for them.

The findings brought to the fore, prices for the 10 most critical drugs to treat COVID-19 have risen a highly unusual 4 percent globally, during the crisis. The cost for over half of these essential COVID-19 medicines rose across 80 countries between February and June 2020. Let me illustrate this point with one example each of Covid-19 emergency treatment options, starting with the global outcry for the same.

Global skepticism on remdesivir pricing:

As the world anxiously awaits a Covid-19 vaccine to hit the market, an experimental repurposed older drug – remdesivir of Gilead Sciences Inc. was introduced as an emergency treatment option for this infection. Pending detail clinical trial results, currently the drug has received only emergency regulatory approvals with an expectation that it may shorten the recovery period in some severely ill Covid-19 patients.

Gilead Sciences, on June 29, 2020, announced its price of $2,340 for a typical treatment course for people covered by government health programs in the United States and other developed countries.However, it will cost $3,120 for patients with private insurance. This price was swiftly and widely criticized, because the drug has received at least $70 million in public funding toward its development - the report highlighted.

Elaborating what would be affordable pricing for this drug in the developed world, another reportquoted the watchdog group – Public Citizen. This group maintains $1 per day is fair. It points to a cost-recovery model developed by the University of Liverpool, which calculated that the cost of manufacturing remdesivir at scale would be 93 cents per dose, leaving the remainder as, in its view, “a reasonable profit to Gilead,” as the report underscored.

Interestingly, analysts expect Gilead to make $525 million on remdesivir sales this year and $2.1 billion next year. This isn’t the first time Gilead is facing public criticism on life saving drug pricing. Just to recap, in 2013, the company also received ‘brickbats’ for its $84,000 price tag for groundbreaking hepatitis C treatment Sovaldi—followed up by its combo pill Harvoni, priced at $94,500. But those were first in class new and innovative drugs. Nevertheless, the remdesivir pricing issue is viewed differently, because it is not just a repurposed older drug, but indicated to combat a global public health crisis.

Let me now give an Indian example on a similar issue, but with a different anti-Covid-19 drug.

Criticism in India with Covid- 19 drug pricing: 

The Drug Controller General of India (DCGI) had on June19, 2020 approved anti-viral drug favipiravir, manufactured in India by Glenmark Pharmaceuticals Ltd. This approval was for “restricted emergency use” of the drug in mild to moderate cases of COVID-19 in the country, in view of the urgent medical need during the pandemic. Favipiravir is made under the brand name Avigan by Japan’s Fujifilm Holdings Corp and was approved for use as an anti-flu drug there in 2014.

According to media reports, Glenmark launched the drug on June 20, 2020 with the brand name FabiFlu at a price of Rs 103 per tablet. On this pricing issue, a member of the Indian Parliament, reportedly, made a representation to the DCGI stating, as a patient has to take 122 tablets of the drug in 14 days, the total cost of the treatment will come to around Rs 12,500. The M.P argued, “price quoted for this drug is definitely not affordable to the common people,” and ‘is definitely not in the interest of the poor, lower middle class and middle-class people of India.’ Additionally, the submission mentioned that ‘Glenmark has also claimed that this drug is effective in co-morbid conditions like hypertension, diabetes, whereas in reality, as per protocol summary, this trial was not designed to assess the FabiFlu in comorbid condition,’ as the letter read.

However, on July 13, 2020, Glenmark reportedly said that it had reduced Favipiravir price from Rs103 to Rs75 per tablet. The Company said, “The price reduction has been made possible through benefits gained from higher yields and better scale, as both the API (Active Pharmaceutical Ingredient) and formulations are made at Glenmark’s facilities in India, the benefits of which are being passed on to patients in the country.”

Thereafter, as reported on July 19, 2020, after receiving a complaint from a member of Parliament, the DCGI sought a clarification from Glenmark over its alleged “false claims” about the use of FabiFlu on Covid-19 patients with comorbidities, including the “pricing” of the drug.

In response Glenmark stated, “Compared to other therapies approved for emergency use in Covid-19, FabiFlu is much more economical and an effective treatment option.” The comparing argued, the estimated total cost for the full course of Favipiravir is Rs 9,150. Whereas, the same for Remdesivir, Tocilizumab and Itolizumab will come to Rs 24,000-30,000, Rs 44,000 and Rs 32,000, respectively.

Importantly, seriously ill Covid-19 patients will often be given many of these drugs, such as, tocilizumab, remdesivir and favipiravir, either one after the other, or simultaneously, making the overall price of treatment hefty for many. From this perspective, the bottom line is, Covid-19 drug treatment in India – where the out of pocket drug expenses is one of the highest in the world, won’t be affordable to many. Besides, there are other critical issues related to Covid-19 drug access and availability to Indian patients. The question that surfaces in this situation, are Covid-19 drug prices are high where there is no or less competition. If, so this is an avoidable situation.

Could this be due to less or no competition?

Continuing with the example of Favipiravir against the above backdrop, Cipla also, reportedly, received the DCGI approval for the launch of experimental Covid-19 drug Favipiravir in India on July 24, 2020. The brand will be marketed under the brand name Ciplenza in the first week of August and is priced much less than Glenmark’s Favipiravir – at Rs 68 per tablet. Could this be due to market competition?

Possibly so, because another report of July 25, 2020 indicated, nearly 10 other Favipiravir formulations will be launched shortly, despite inconclusive scientific clinical evidence as on date. Favipiravir price is expected to fall further due to competition. In that case, what could be the takeaway message, when this price trend is viewed against the response of Glenmark to the DCGI letter, justifying FabiFlu pricing?

Other issues of Covid-19 drug availability and access to Indian patients:

Other critical issues related to Covid-19 drug availability and access to Indian patients include, prices of Covid-19 drugs shooting up in short supply. There have been reports of difficulty in accessing remdesivir in India, too, although, Gilead Sciences has licensed this drug out to a few Indian generic pharmaceutical companies such as Hetero Healthcare, which has announced that it would manufacture and sell it at Rs 5,400 per vial. According to the latest protocol of the health ministry, the dosage of remdesivir should be 200 mg IV on day 1 followed by 100 mg IV daily for 4 days (5 days in total). From this one can easily work out the treatment cost with remdesivir for each patient.

Moreover, a BBC investigation has found that two life-saving drugs used to treat Covid-19 patients in India – remdesivir and tocilizumab – are in short supply and being sold for excessive rates on a thriving black market. Yet another recent investigation has unraveled a growing black-market for plasma therapy, ‘born out of the desperation of families willing to do anything to save their loved ones infected with Covid-19.’

I am citing these examples to give a sense of the plight of common Covid-19 patients from the drug availability, affordability and accessibility perspective – to save lives. However, the good news is, in this otherwise gloomy scenario, as perceived by many, a more empathetic scenario has been reported from many Covid-19 vaccine manufacturers.

More empathetic scenario with Covid-19 vaccine manufacturers: 

According to the World Health Organization (W.H.O), over 160 groups are working on COVID-19 vaccines, and 24 candidates have already reached human testing, Some are, reportedly gearing up for phase 3. It is widely expected, vaccines might be ready later this year or early next year. Vaccine developers are racing ahead at record speed, supported by Governments and facilitated by the drug regulators, to translate billion dreams coming true amid a public health catastrophe.

For the world population to acquire immunity against the Covid-19 onslaught, the key question remains: ‘At what price’, when vaccines are available? According to reports, the encouraging news is, some major vaccine makers, such as:

  • AstraZeneca (with Oxford University) plans to price at “no profit” during the pandemic “to support broad and equitable access around the world.” The company has entered several agreements with governments and other groups to provide about 2 billion doses around the world, at no profit.
  • Similarly, J&J has also “committed to bringing a safe and effective vaccine to the public on a not-for-profit basis for emergency pandemic use.”
  • Pfizer CEO has also said the company “will make a very, very marginal profit at this stage.” He pointed out that the company hasn’t taken any governmental funding, unlike other players. The company and its partner BioNTech have entered a deal with the U.K. government for 30 million doses. Moreover, Pfizer and BioNTech will get $1.95 billion from the US government to produce and deliver 100 million doses of their Covid-19 vaccine candidate.
  • Moderna CEO said, there’s “no world, I think, where we would contemplate to price this higher than other respiratory virus vaccines.”
  • Sanofi, which has separate COVID-19 vaccine partnerships with GlaxoSmithKline and Translate Bio, has “been committed to working with governments, partners and payers to ensure that when new vaccines are approved, we will make them available and affordable,”
  • Merck CEO also said the company has committed to “broad, equitable, affordable access.”
  • Nearer home, Serum Institute of India, has pledged to make 1 billion doses of the Oxford-AstraZeneca jointly formed COVID-19 vaccine at under Rs1000 per shot. The production could start as early as first quarter next year. Company CEO said this is not the time to make money from a vaccine against the novel Coronavirus, which has caused a global pandemic.

These pledges do give a comfort to many. Because, unlike Covid-19 repurposed older drug manufacturers, Covid-19 vaccine makers seem to be more empathetic to make these accessible and available to the world population at an affordable price.

Conclusion:

Well past a million mark, as on July 26, 2020 morning, the recorded Coronavirus cases in the country reached 1,339,176 with 31,425 deaths. With the number of daily cases being more than Brazil, India is poised to bridge its gap with the South American country. The steep unenviable climb continues.

The July 21, 2020 article – ‘Drug Pricing Back in the Spotlight,’ published in the PharmaExec.com, quoted the ICER Executive Vice-President saying,’ the drug pricing conversation is different in a pandemic.’ The system needs to ensure public access to drugs and vaccines in this global health crisis. If it does not happen, I reckon, appropriate authorities must step in with specific remedial measures.

Otherwise, the kudos showered on the drug industry for promptly offering a number of repurposed older drugs for emergency use against Covid-19 may not last long, if these treatments are not affordable and accessible to a vast majority. From this perspective, the questions being raised on accessibility, affordability and availability of many Covid-19 drugs, need to be addressed and resolved – soon.

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.

Supreme Court Intervened…But ‘Price Control’ needs striking a right balance between ‘Affordability’ and ‘Availability’ of medicines for Patients’ Sake

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On October 3, 2012, the Supreme Court bench of Justice GS Singhvi and Justice SJ Mukhopadhayareportedly asked the government not to disturb the existing price control mechanism while including all medicines featuring  in the National List of Essential Medicines 2011 (NLEM 2011) therein and posted the matter for further hearing on October 11, 2012.

This happened during the hearing of a Public Interest Litigation (PIL) filed by All India Drugs Action Network (AIDAN) and others, way back in 2003, complaining that the span of price control of only 74 bulk drugs and their formulations under the existing Drugs Prices Control Order, 1995 (DPCO  95) does not include lot many essential medicines, making those drugs unaffordable to the general population.

It is worth mentioning that during earlier hearing on the subject the council of the petitioner had expressed apprehensions to the honorable Supreme Court that the proposed Drug Policy recommending Market Based Pricing may lead to a steep increase in prices of essential medicines in India.

The purpose of ‘Price Control’:

As we know, the key purpose of the Drug Price Control in India is to ensure adequate access to essential medicines for the common man. To achieve this objective meaningfully, the process that the price regulator should follow must always ensure that all such medicines are:

  • Adequately Available
  • Reasonably Affordable

Therefore, maintaining a right balance between ‘affordability’ and ‘availability’ of medicines, while framing any drug policy, is of critical importance.

DPCO 95 does not meet the above two criteria: 

The prevailing price control mechanism has failed to meet the above two critical criteria. This is mainly because the following 26 out of 74 bulk drugs featuring in DPCO 95, though still very important, are not currently manufactured in India due to unremunerative pricing:

No

Molecule

Therapeutic Segment

No.

Molecule

Therapeutic Segment
AMODIAQUIN Anti-Malarial 14. SULPHADIMIDINE Anti-Infective
CAPTOPRIL Anti-Hypertensive 15. SULPHAMOXOLE Anti-Infective
CHLORPROPAMIDE Anti-Diabetic 16. HALOGENATED HYDROXYQUINOLONE Anti-Infective
SALAZOSULPHAPYRINE Gastrointestinal 17. TRIMIPRAMINE Anti-Depressant
MEBHYDROLINE Anti-Histamine 18. LYNESTRANOL Hormone
CHLOROXYLENOLS Anti-Infective 19. METHENDIENONE Steroid
CEPHAZOLIN Anti-Infective 20. DIOSMINE Anti- Haemorrhoidal
PENICILLINS Anti-Infective 21. PYRANTEL Anthelmintic
NALIDIXIC ACID Anti-Infective 22. PYRITHIOXINE Vitamin
STREPTOMYCIN Anti-Infective 23. VITAMIN-B1  (THIAMINE) Vitamin
CHLORPROMAZINE Anti-Psychotic 24. VITAMIN-B2 (RIBOFLAVIN) Vitamin
BECAMPICILLIN Anti-Infective 25. PANTHONATES & PANTHENOLS Vitamin
SULPHADOXINE Anti-Infective 26. VITAMIN E Vitamin

(Source: BDMA-26th May 2012)

This makes one to conclude that the honest attempt of the government to make the above drugs affordable to the patients through DPCO 95 has resulted into their non-availability, making ‘affordability’ irrelevant. Thus, such a mechanism defeats the core purpose of any drug price regulation and should not be continued with.

What happens when NLEM 2011 is included in DPCO 95?

As explained above, if all the essential medicines featuring in the NLEM 2011 are brought under DPCO 95, solely to make them more affordable to patients, there will be a high possibility that market factors, as stated above, may make many of these important medicines unavailable to the patients, as happened in case of so many bulk drugs covered under DPCO 95.

Search for a balancing formula: 

To correct this imbalance between availability and affordability of essential medicines, there is an urgent need to first work out a balancing formula and then build that into the new price control mechanism, jettisoning DPCO 95.

This will help addressing the issue of improving access to essential medicines for the common man in India much more meaningfully.

Dr. Pronab Sen Committee Report vindicates the point:

In 2005, to explore this possibility, the government constituted a special taskforce, which is widely known as ‘Dr. Pronab Sen Committee’. This committee was mandated to recommend options other than existing methodology of price control (DPCO 95) for achieving the objective of making available life-saving and essential drugs at reasonable prices.

In its report, the committee did suggest an alternative measure at that time, concluding that the present price control system (DPCO 95) is inappropriate, inadequate, cumbersome and time consuming.

High transaction costs make essential medicines more expensive:

Current transaction costs of medicines in India are over 50 percent of their ex-factory cost, excluding Excise Duty (ED). The various components of the transaction cost include ED, VAT, CST etc. and distribution (trade) margin.

As the Honorable Supreme Court arrives at the final decision on price control measures for NLEM 2011, there is a need for the government to abolish all duties and taxes like ED, VAT, CST etc. levied on such medicines for the sole benefits of the patients.

For an important policy decision involving essential drugs, all ‘patient centric’ cost-cuts, in my considered view, should be shared by both the government and the Pharmaceutical Industry together.

‘Drug Price’ control alone cannot improve access to medicines significantly: 

It is a recognized fact that to improve access to medicines, the Governments even in countries like, Germany, Spain, UK, Korea, Brazil and China have recently mulled strict price control measures in their respective countries.

However, it is equally important to note that in India, we have witnessed since almost the past four decades that drug price control alone could not improve access to modern medicines for the common man very significantly, especially in the current socioeconomic and healthcare environment of the country. Thus, there is a dire need to augment other healthcare access related initiatives in tandem for a holistic approach.

Recently the Government of India has taken ‘Public Health Interest’ oriented a landmark initiative of providing unbranded generic formulations of all essential drugs, featuring in the ‘National List of Essential Medicines 2011’, free of cost to all patients from the public hospitals and dispensaries, across the country. This laudable step could well address the issue of availability and affordability of essential drugs for a vast majority of the population in India.

Taming drug price inflation only has not helped improving access to medicines: 

It is quite clear from the following table that food prices impact health more than medicine costs:

Year

Pharma Price Increases

Food Inflation

2008

1.1%

5.6%

2009

1.3%

8.0%

2010

0.5%

14.4%

(Source: CMIE)

Exploring a realistic approach:

Imbibing the direction, as provided in ‘Dr. Pronab Sen Committee Report’ and considering other pros and cons of the key methodologies of price control of formulations featuring in NLEM, I wouldreemphasize that a middle path with a win-win strategy to overcome the weaknesses of DPCO 95 effectively, would be in the best interest of both patients and the industry alike, in the current situation. This path, I reckon, may be explored as follows with a four step approach:

  • The inclusion criteria for price control in the new Drug Policy should be based on the ‘essentiality’ criteria of the drugs, which will mean all formulations featuring in the NLEM, as announced by the Ministry of Health from time to time, will come under price control.
  • Take ‘Weighted Average Price’ of each formulation featuring in the National List of Essential Medicines (NLEM) based on Maximum Retail Prices (MRP) of all brands of high, medium and low, above a certain cut-off point, if required.
  • Abolish all duties and taxes like ED, VAT, CST etc. as currently being levied on essential medicines and rationalize high trade margins of total 24 percent to further improve affordability of such drugs to the patients.
  • Put in place effectively enough checks and balances to ensure proper availability of NLEM drugs for all and also to avoid any possible situation of artificial shortages of such drugs. 

Conclusion:

Come October 11, 2012, let us hope that the honorable Supreme Court of India will pass an order related to drug price control, which will help striking a right balance between ‘availability’ and ‘affordability’ of essential medicines in India and the government will rationalize the transaction costs of such medicines thereafter.

In that case, it will be a win-win solution both for the patients and the industry alike, paving the way for improving access to essential medicines for the entire population of India along with other related strategic initiatives towards this goal. Such measures are absolutely essential, especially when medicines contribute around 72 percent of the total ‘Out of Pocket Expenses’ of the common man of the country.

That said, it is important to realize that there is no single or only right way to arrive at the ‘affordable price’ of any medicine, essential or otherwise. However, how much the government or an apex court will allow the pharmaceutical manufacturers to charge for a drug to make the prices ‘reasonably affordable’, will continue to remain an important, complex and a difficult task, both locally and globally.

By: Tapan 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.