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Access To Comprehensive Healthcare Merits Multipronged Approach

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Since the turn of the new millennium, several high profile and flagship health schemes are being announced in India by the Union successive governments. Some of the important ones will include the National Health Mission, Rashtriya Swasthya Bima Yojana (RSBY) - a Health Insurance Scheme for the Below Poverty Line families and now Ayushman Bharat – National Health Protection Mission - expected to cover over 100 million poor and vulnerable families providing coverage up to 500,000 rupees per family per year for hospitalization related to secondary and tertiary care.

Besides, the Mental Health Care Act 2017 has been operational since last year. It was passed by the Rajya Sabha in August 2016, and the Lok Sabha on March 2017. The right to mental health care is the core of the Act.

Each of these announcements look good on paper and was accompanied with lofty government promises. Riding on the waves of hypes thus created, public expectations increased commensurately for getting easy access to a comprehensive and affordable health care, which now includes ‘Mental Health’ as well. Unfortunately, the Gordian knot in Indian public healthcare space continued to exist. As various reports  indicate, for example, one that appeared on November 27, 2018, – even Ayushman Bharat is apparently moving towards the same detection driven by some critical basic issues.

Consequently, scores of people still do not have adequate and affordable access to basic health care, including essential drugs – clamping price control notwithstanding. The government knows it well, as it increases vigil on drug pricing. Pharma industry also feels its scorching heat. Overall storyline remains mostly unchanged. The vicious cycle continues.

In this article, I shall dwell on a system-approach to delivering comprehensive public health care. The key objective is trying to figure out what is the core problem that most of these schemes are either not addressing or doing it with a ‘band-aid’ approach. One of the key requirements for improving access to health care significantly, I reckon, is a clear understanding on the characterizations of the critical stages of healthcare access and their dimensions, from the patients’ perspective.

However, before doing so, let me glance upon some health care related current and important facts, as uploaded in the government’s National Health Profile 2018.  

National Health Profile 2018:

As available in the National Health Profile (NHP) of India – 2018, following are some of the important facts, which are worth noting:

  • In the current budget year, public (government) spending on health is just 1.3 per cent of the GDP against the global average for the same at 6 percent.
  • Just one doctor serves a population of 11,000 people, which is way below W.H.O recommended a doctor to population ratio of 1:1,000. The scenario is even worse in many states, such asBihar with 1: 28,391, Uttar Pradesh records 1:19,962, Jharkhand with 1:18,518, Madhya Pradesh shows 1:16,996 and Chhattisgarh at 1:15,916.
  • Per capita public expenditure by the government on health, stands at Rs 1,112 that comes to Rs 3 per day. This puts India below other low-income nations like the Maldives (9.4), Bhutan (2.5), Sri Lanka (1.6) and Nepal (1.1).

These numbers provide just a flavor of the Indian healthcare space, as it stands today. Some may of course talk about legacy factor, but to move ahead more important for all is what is happening today in this regard. Yes, one more health mission, as mentioned above, has been launched on September 25, 2018 with similar hype as the past ones, if not more. Only the future will tell us what changed it brings to the ground. That said, I am not very upbeat about it either, as providing a comprehensive health care access has always been multi-factorial and will remain so. Let me now dwell on why I am saying so.

Understanding health care access:

The 2013 research paper on “Improving Healthcare Access in India” by erstwhile IMS Consulting group (now IQVIA), said that ‘health care access characterizes 3 stages,’ which from the patient’s perspective has 4 key dimensions. In the Indian context, these three stages are:

  • Accessing care: Physical reach and location
  • Receiving care: Availability/capacity, Quality/functionality
  • Paying for care: Affordability

Accordingly, healthcare access is a function of 4 key aspects:

  • Physical reaches to health care facility
  • Availability of doctors and medicines in those places
  • Quality of care provided by these centers
  • Affordability of treatment, if available there

Access to healthcare is slowly improving, but far from being enough:

All the above schemes of the government are primarily focused on ‘paying for care’ stage and ‘affordability’ of treatment, including drugs. To a limited extent it makes sense as the above study vindicates that ‘availability’ and ‘affordability’ have good impact on ‘access to health care’.

Since the inception of NHM, this approach, no doubt, has made some improvement in the overall access to health care in the country, as many studies indicate. The IMS Consulting study also observes that compared to 2004, more patients received free medicines in outpatient care in 2013 – over 50 percent of patients going to Government hospitals say that they get free medicines there. However, the outcomes of the same across the Indian states vary quite a lot.

Inadequate healthcare infrastructure and physical reach in rural areas:

Having noted that, grossly inadequate availability of public health care infrastructure – or when available physical access to many of those from remote villages, coupled with lack of availability of required doctors, paramedics, nurses and medicines in those dispensaries – often become major issues. Moreover, their capacity to providing quality care, besides longer waiting time, often pushes many – either to remain virtually untreated or to go to private care centers costing much more.

The study finds that such movement of people from public to private facilities leads to higher health care costs. Consequently, high usage of private channels drives up the out of pocket (oop) cost of treatment. Some of the details are as follows:

  • 74 percent of patients sought private consultation
  • 85 percent of ‘oop’ spending on health care was in the private sector
  • 81percent of patients incurred ‘oop’ expenditure for medicines

Curiously, 35 percent of patients in the study rated public health facilities as – good. Whereas an overwhelming 81 percent said so for private facilities. Nevertheless, associated high ‘oop’ expenditure for the same often becomes an economic burden. The large number of patients with chronic ailments, are the major sufferers.

Application of mobile-health could help improve access:

On improving access to health care in India, an interesting ‘Review Article’ titled, “Applications of m-Health and e-Health in Public Health Sector: The Challenges and Opportunities”, appeared in the International Journal of Medicine and Public Health, April-June, 2018 issue, makes some thought-provoking observations.

It says, while the use of mobile phone (MPs) has become commonplace in many industry sectors, such as banking, railways, airlines – the public health sector has been somewhat slow in adopting MP technologies into routine operations. Its innovative use can benefit patients and providers alike by enhancing access to health care.Smartphones’ usefulness in the treatment of chronic diseases – for example, monitoring of blood pressure, blood sugar, body weight, electro- cardiograph (ECG), has already been established.

The paper also suggests, mobile health (m-H) is more effective when tailored to specific social, ethnic, demographic group using colloquial language. If implemented craftily and systematically, m-H can revolutionize the scenario of the health care delivery system, in many ways. Optimal doctor-patient engagement policy for m-H needs to be formulated, outlining a legal framework and with multi-stakeholder collaboration.

Mental health still largely ignored:

Another important aspect of comprehensive health care is ‘Mental Health’, as more than 60 million Indians suffer from mental disorders, suicides being one of the major killers in India (Source: W.H.O, IndiaSpend). However, it is disturbing to note that awareness and access to mental health treatment, especially in the hinterland of the country, continue to remain ignored. Increasing incidences of farmers’ suicides, for example, notwithstanding.

This was further elaborated by the IndiaSpend report of January 30, 2018, which underscored:“Allocation to the National Program for Mental Health has been stagnant for the past three years. At Rs 350 million, the program received 0.07 percent of India’s 2017-18 health budget.This is despite the fact that an estimated 10-20 million Indians (1-2% of the population) suffer from severe mental disorders such as schizophrenia and bipolar disorder, and nearly 50 million (5 percent of the population) – almost equal to the population of South Africa–suffer from common mental disorders such as depression and anxiety.”

The report further highlights that, notwithstanding 15 suicides every hour and 133,623 suicides in 2015, India is short of 66,200 psychiatrists and 269,750 psychiatric nurses. It is also noteworthy, while a frugal sum of 0.06 percent of India’s health budget is for mental health care, the same for even Bangladesh stands at 0.44 percent (Source: W.H.O, IndiaSpend).

Conclusion:

From the above perspective, I reckon, although access to health care in India, except ‘mental health care’, is improving at a modest pace, it doesn’t seem to be anywhere near adequate, as on date. A holistic approach for a comprehensive health care access to all, through the public health system, seems to be the need of the hour.

That said, currently India is not meeting the minimum W.H.O recommendations for healthcare workforce and also in bed density. A large section of the population continues to lack affordable access to quality health care. Moreover, the importance of mental health is still unknown to many in the country.

Thus, in tandem with addressing all the three stages and four key dimensions of comprehensive health care access, it is imperative to leverage new technology-based       e-healthcare and digital devices like m-Health. Together, these will help provide and facilitate not just quality care to patients, but also complement the healthcare infrastructure, including doctors and paramedics – making quality and affordable health care accessible to all.

As I said in my article, titled ‘Mental Health Problem: A Growing Concern in The Healthcare Space of India, the ‘Mental Health Care Bill’, which is now an Act, redefines mental illness to better understand various conditions that are persistent among the Indian population.This is a good development, as it aims at protecting the rights of persons with mental illness and promote access to mental health care. Since, the current ground reality in this area is a cause of great concern, when will it be effectively implemented for all, is the all-important question.

It is imperative for all concerned to understand that improving access to comprehensive health care is multi-factorial issue. Therefore, it needs nothing less than a well-thought out multi-pronged approach for an effective solution.

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.

High Innovation-Cost Makes Cancer Drugs Dear: A Fragile Argument?

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Cancer is a major cause of high morbidity and mortality in India, just many other countries, according to a report of the World Health Organization (W.H.O). While deaths from cancer worldwide are projected to continue to rise to over 1.31 million in 2030, the Indian Council of Medical Research (ICMR) estimates that India is likely to have over 1.73 million new cases of cancer and over 8,80,000 deaths due to the disease by 2020 with cancers of breast, lung and cervix topping the list.

 Cancer treatment is beyond the reach of many:

Despite cancer being one of the top five leading causes of death in the country, with a major impact on society, its treatment is still beyond the reach of many. There are, of course, a number of critical issues that need to be addressed in containing the havoc that this dreaded disease causes in many families –  spanning across its entire chain, from preventive measures to early diagnosis and right up to its effective treatment. However, in this article, I shall focus only on the concern related to affordable treatment with appropriate cancer with medicines.

To illustrate this point, I shall quote first from the address of the Chief Minister of Maharashtra during inauguration of Aditya Birla Memorial Hospital Cancer Care Center on November 26, 2016. He said: “Cancer is the dreadful disease of all the time and for Maharashtra it is a big challenge as we are infamously at number two position in cancer cases in the country as after Uttar Pradesh, most cases are found here.” Incidentally, UP is one of the poorest state of India.

Underscoring that the biggest challenge before the technology is to bring down the cost of the cancer treatment and make it affordable and accessible for all, the Chief Minister (CM) further observed, “although, technological innovation has increased in last one decade, the accessibility and affordability still remain a challenge and I think, we need to work on this aspect.”

A new cancer drug launch vindicates the CM’s point:

The Maharashtra CM’s above statement is vindicated by a national media report of September 13, 2017. It said, Merck & Co of the United States have launched its blockbuster cancer drug ‘Keytruda’ (pembrolizumab) in India, around a year after its marketing approval in the country. Keytruda is expected to be 30 percent cheaper, compared to its global prices, costing Rs 3,75,000 – 4,50,000 to patients for each 21-day dose in India.

The point to take note of, despite being 30 percent cheaper, how many Indian patients will be able to afford this drug for every 3 weeks therapy? Doesn’t it, therefore, endorse the CM’s above submission? Well, some may argue that this exorbitant drug price is directly linked to high costs for its innovation and clinical development. Let me examine this myth now under the backdrop of credible research studies.

Cancer drugs are least affordable in India – An international study:

On June 6, 2016, by a Press Release, American Society of Clinical Oncology (ASCO) revealed the results of one of the largest analyses of differences in cancer drug prices between countries worldwide. The researchers calculated monthly drug doses for 15 generic and eight patented cancer drugs used to treat a wide range of cancer types and stages. Retail drug prices in Australia, China, India, South Africa, United Kingdom, Israel, and the United States were obtained predominantly from government websites. The study shows that cancer drug prices are the highest in the United States, and the lowest in India and South Africa.

However, adjusting the prices against ‘GDPcapPPP’ – a measure of national wealth that takes into consideration the cost of living, cancer drugs appeared to be least affordable in India and China. The researchers obtained the ‘GDPcapPPP’ data for each country from the International Monetary Fund and used it to estimate the affordability of drugs.

Why are cancer drug prices so high and not affordable to many?

The most common argument of the research based pharma companies is that the cost of research and development to bring an innovative new drug goes in billions of dollars.

The same question was raised in a series of interviews at the J.P. Morgan Healthcare Conference, published by the CNBC with a title “CEOs: What’s missing in the drug pricing debate” on January 11, 2016, where three Global CEOs expressed that the public is getting overly simple arguments in the debate about drug pricing. All three of them reportedly cited three different reasons altogether, as follows:

  • Eli Lilly CEO said, “Some of the noise you hear about drug pricing neglects the fact that we often must pay deep discounts in a market-based environment where we’re competing in many cases against other alternative therapies, including those low-cost generics.”
  • Pfizer CEO took a different approach by saying, “if you look at the market, about a decade ago, 54 percent of the pharmaceutical market was genericized; today 90 percent is genericized.”
  • However, as reported by CNBC, Novartis CEO Joseph Jimenez, focusing on innovation and in context on cancer drugs, argued “innovation has to continue to be rewarded or we’re just not going to be able to see the kind of breakthroughs that we have seen in cancer research, specifically regarding the uses and benefits of the cancer-fighting drug Gleevec. We continued to show that the drug was valuable in other indications in cancer and so we needed to be reared for that innovation and we’re pricing according to that.”

Is drug innovation as expensive and time intensive as claimed to be?

An article titled, “The high cost of drugs is the price we pay for innovation”, published by the World Economic Forum (WEF) on March 28, 2017 reported, “15 spenders in the pharmaceutical industry are investing about US$3 billion in R&D, on average, for each successful new medicine.”

The November 18, 2014 report on the ‘Cost of Developing a New Drug,’ prepared by the Tufts Center for the Study of Drug Development also announced: “The estimated average pre-tax industry cost per new prescription drug approval (inclusive of failures and capital costs) is: US$ 2,558 million.”

Not everybody agrees:

Interestingly, Professor of Medicine of Harvard University – Jerry Avorn questioned the very basis of this study in the article published in the New England Journal of Medicine (NEJM) on May 14, 2015. It’s not just NEJM even the erstwhile Global CEO of GSK – Sir Andrew Witty had questioned such high numbers attributed to R&D cost, around 5 years ago, in 2013. At that time Reuters reported his comments on the subject, as follows:

“The pharmaceutical industry should be able to charge less for new drugs in future by passing on efficiencies in research and development to its customers. It’s not unrealistic to expect that new innovation ought to be priced at or below, in some cases, the prices that have pre-existed them. We haven’t seen that in recent eras of the (pharmaceutical) industry, but it is completely normal in other industries.” Quoting the study of Deloitte and Thomson Reuters on R&D productivity among the world’s 12 top drugmakers that said the average cost of developing a new medicine, including failures, was then US$ 1.1 billion, Witty remarked, “US$ 1 billion price-tag was one of the great myths of the industry.”

A decade after Sir Andrew’s comment, his view was virtually corroborated by yet another research study, published this month. The study reemphasized: “The Tufts analysis lacks transparency and is difficult to judge on its merits. It cannot be properly analyzed without knowing the specific drug products investigated, yet this has been deemed proprietary information and is governed by confidentiality agreements.” I shall discuss this report briefly, in just a bit.

The latest study busts the myth:

The latest study on the subject, titled “Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval”, has been published in the ‘JAMA Internal Medicine’ on September 11, 2017. It busts the myth that ‘high innovation-cost makes cancer drugs dear,’ providing a transparent estimate of R&D spending on cancer drugs. Interestingly, the analysis included the cost of failures, as well, while working out the total R&D costs of a company.

The report started by saying: “A common justification for high cancer drug prices is the sizable research and development (R&D) outlay necessary to bring a drug to the US market. A recent estimate of R&D spending is US$ 2.7 billion (2017 US dollars). However, this analysis lacks transparency and independent replication.”

The study concludes: “Prior estimates for the cost to develop one new drug span from US$ 320.0 million to US$ 2.7 billion. We analyzed R&D spending for pharmaceutical companies that successfully pursued their first drug approval and estimate that it costs US$ 648.0 million to bring a drug to market. In a short period, development cost is more than recouped, and some companies boast more than a 10-fold higher revenue than R&D spending—a sum not seen in other sectors of the economy. Future work regarding the cost of cancer drugs may be facilitated by more, not less, transparency in the biopharmaceutical industry.” The researchers also established that ‘the median time to develop a drug was 7.3 years (range, 5.8-15.2 years).’

“Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation”:

NPR – a multimedia news organization and radio program producer reported: In an invited commentary that accompanies the JAMA Internal Medicine analysis, Merrill Goozner, editor emeritus of the magazine Modern Healthcare, noted that “the industry consistently generates the highest profit margins among all U.S. industries.” Goozner argues that the enormous value of patent protection for drugs far outweighs the inherent riskiness of pharmaceutical research and development, and agrees with the study authors when he writes: “Policymakers can safely take steps to rein in drug prices without fear of jeopardizing innovation,” NPR wrote.

Conclusion:

So, the moot question that surfaces: Is Pharma innovation as expensive and time consuming as claimed to be? If not, it further strengthens the credibility barrier to Big Pharma’s relentless pro-innovation messaging. Is the core intent, then, stretching the product monopoly status as long as possible – with jaw dropping pricing, unrelated to cost of innovation?

Further, incidents such as, shielding patent of a best-selling drug from low priced generic competition, by transferring its patents on to a native American tribe, probably, unveil the core intent of unabated pro-innovation messaging of major global pharma companies. In this particular case, being one among those companies which are seeking to market cheaper generic versions of this blockbuster eye drug, Mylan reportedly has decided to vigorously oppose such delaying tactic of Allergan before the Patent Trial and Appeal Board.

As a cumulative impact of similar developments, lawmakers in the United States are reportedly framing new laws to address the issue of high drug prices. For example, “California’s Senate Bill 17 would require health insurers to disclose the costs of certain drugs and force pharmaceutical manufacturers to detail price hikes to an agency for posting on a government website. The proposal would also make drugmakers liable to pay a civil penalty if they don’t follow its provisions.”

The myth of ‘high innovation-cost makes cancer drugs dear’ will go bust with such revelations, regardless of the blitzkrieg of self-serving pro-innovation fragile messaging.  Alongside, shouldn’t the Indian Policy makers take appropriate measures to rein in cancer drug prices, being free from any apprehension of jeopardizing innovation?

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.

 

Mental Health Problem: A Growing Concern In The Healthcare Space Of India

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A thud!

Something fell from high above!

In no time, a bright young life of just a 32-year-old highly accomplished professional – a widely admired soul, vanished in the thin year, for good, mostly unnoticed in the quiet neighborhood, initially.

The news was more than a shock to my family. It engulfed me by the fire of impotent rage against this cruel play of destiny, where nothing can be undone, just nothing!

What prompted this so bright, successful, hugely promising and an ever-helpful-to-all guy doing what he did? No one could ferret out the answer, just yet, and possibly would never be.

Medical literatures have now established a close relationship between depression and its possible lethal outcome – suicide. Using literature data, one can estimate that 60 to 70 percent of the subjects attempting suicide were suffering from depression of various kinds. Was this young man too silently suffering from this undiagnosed and untreated mental illness?

In this article, I shall dwell on this important aspect of overall health care in India.

Depression ranks 4th in the 10 leading causes of the global burden of disease:

The World Health Organization (W.H.O) underlines: “Major depression is now the leading cause of disability globally and ranks fourth in the ten leading causes of the global burden of disease. If projections are correct, within the next 20 years, depression will have the dubious distinction of becoming the second cause of the global disease burden. Globally, 70 million people suffer from alcohol dependence. About 50 million have epilepsy; another 24 million have schizophrenia. A million people commit suicide every year. Between ten and 20 million people attempt it.”

A recent study:

Currently in India, millions of people with mental illnesses continue to remain untreated. This is vindicated by a chain of recent research studies titled, “China-India Mental Health Alliance Series”, published in ‘The Lancet’ on May 18, 2016.

The studies highlighted that: “China and India, which together contain 37 percent of the world’s population, are both undergoing rapid social changes. Because mental disorders account for a high proportion of morbidity, detailed knowledge of the mental health status of the populations in these two countries, and the evidence-base regarding the treatment of those disorders, are of paramount concern.”

“In China, mental, neurological and substance use disorders accounted for 7 percent of all (years of healthy life of the whole population) in 1990, rising to 11 percent by 2013. Similarly, in India, the proportion of all burden explained by mental, neurological, and substance use disorders rose from 3 percent in 1990 to 6 percent in 2013,” the researchers highlighted.

Greater concern in India:

In 2013, 36 million years of healthy life were lost to mental illness in China, and 31 million in India. The new research estimates that by 2025, though 36.9m years of healthy life will be lost to mental illness in China (10 percent increase), it will be 38.1m in India (23 percent increase). Anxiety and depression are the most common mental health problems among working age adults between 20 and 69 years.

Similarly, dementia is emerging as a growing mental health issue for both countries. However, from 2015 to 2025, it is estimated that the number of healthy years lost due to dementia will increase by 82 percent in India against 56 percent in China.

Interestingly, in August 2016, replying to a debate on the ‘Mental Health Care Bill’ in the Parliament, the Union Health Minister Mr. J. P. Nadda said, around 6-7 per cent of Indian population suffered from mental illnesses, while 1-2 per cent suffer from acute mental disease.

This means, over 70 million people are affected by mental illness in India, which has a close association with the rate of suicides, cardiovascular disorders, and loss of a significant number of productive days. It is estimated that around 50 percent of people with severe mental disease and around 90 percent of those with less severe symptoms, remain untreated in the country.

Depression, reportedly, the most prevalent form of mental illness that affects almost 3 to 5 percent of urban population living in cities, such as, Mumbai or Delhi. Around 30 percent of them are severely neurotic.

Alzheimer’s disease was reported to be the most common of severe disorders (54 percent) followed by vascular dementia (39 percent).

Another Government statistics indicate that 20 percent of Indians reportedly need counselling at some point of their lives. One per cent of the population suffers from serious mental health disorders, while 5-10 percent of Indians suffer from moderate disorders.

Another recent study:

Another recent report published in ‘The Lancet Psychiatry’ on 12 August 2016, captured the following details for India, in this area:

  • Very few population-representative data were found for mental disorders, with an average coverage of just 1 percent of the country’s population.
  • Major depressive disorder, anxiety disorder, and alcohol dependence were the most common mental, neurological, and substance abuse disorders, for men.
  • For women, anxiety disorder, major depressive disorder, and dysthymia were most common.
  • Human and financial resources for mental health are grossly inadequate with less than 1 percent of the national health care budget allocated to mental health in India.
  • Improvement of coverage will need to address both supply-side barriers and demand-side barriers related to stigma and varying explanatory models of mental disorders.

An associate professor of psychiatry at New Delhi’s All India Institute of Medical Sciences (AIIMS), reportedly said, there is just one psychiatrist for every 400,000 Indians. Apparently, he also said that there are only about 4,000 psychiatrists, 1,000 psychologists and 3,000 social workers in the entire country of over 1.2 billion people. Only 1,022 college seats for mental health professionals are set aside in India.

Or, in other words, a huge dearth of trained mental health professionals, coupled with low public investments, and fueled by high associated stigma, continue to compel many Indian populations lose many years of their lives to the illness.

Role of traditional medicines:

The study also suggests that traditional medicine practitioners, who are so common in India, “may be trained to recognize and refer patients who are at risk to themselves and others, or to advise patients against stopping their medication. Nevertheless, the authors do call for more research in this area to understand the effectiveness and potential risks of traditional medicines in the treatment and management of mental health.

Associated stigma:

It’s worth repeating, unlike many developed countries of the world, there is still a stigma associated with mental health problems in India. There are several instances of its adverse impact, not just on the social level, but also on the employment opportunities. These issues compound the treatment problem, making their public interaction too very weird at times, further increasing social polarization and inequalities.

Not a personal failure:

As the World Health Organization (W.H.O) articulates: “Mental illness is not a personal failure. It doesn’t happen only to other people. We all remember a time not too long ago when we couldn’t openly speak about cancer. That was a family secret. Today, many of us still do not want to talk about AIDS. These barriers are gradually being broken down.”

The Mental Health Care Bill:

The long-awaited ‘Mental Health Care Bill’, which after an extensive consultation process, is now awaiting the lawmakers’ formal approval for its enactment as law. The Bill, was passed by the Rajya Sabha on August 8, 2016, and is expected to be discussed in the Lok Sabha, probably in this budget session. It was first introduced on August 19, 2013, the Rajya Sabha Standing Committee report was submitted on November 20, 2013.

The bill reportedly redefines mental illness to better understand various conditions that are persistent among the population. It states that mental illness is a ‘substantial disorder of thinking, mood, perception, orientation or memory that grossly impairs judgement, behavior, capacity to recognize reality or ability to meet the ordinary demands of life’. Mental conditions related to alcohol or drug abuse are also included in the definition.

The Bill basically aims at protecting the rights of persons with mental illness and promote their access to mental health care.

One of the major highlights of the bill is decriminalization of attempt to suicide, as it states that the person attempting suicide will be presumed to be ‘under severe stress’ unless otherwise proven, and is not punishable. This move is commendable, ‘as it takes away the burden of implicating a mentally ill person in a crime that he or she had no sane control over.’ The W.H.O report on suicides (2000-2012) puts India right on top of the list in Southeast Asia. It says, the average suicide rate in India is 10.9 for every 100,00 people.

Conclusion:

Mental health has now been included in the United Nation’s ‘Sustainable Development Goals (SDG)’ at its General Assembly in September 2015. It is very likely that SDGs addressing mental health issues will become a part of country development plans and of bilateral and multilateral development assistance. This could well mean that millions of people will finally receive much needed help in this area.

Zeroing-in to India, mental health problems have since been a low priority area in the public health narrative of the country. The health information system of the country does not prioritize mental health, either.

To address this growing concern, besides forthcoming enactment of ‘Mental Health Care Bill’, the much-awaited healthcare reform of the nation, should include a transparent policy framework for mental health. A substantial number of community health workers, including traditional medicine practitioners need to be trained to deliver basic mental health hygiene and care. More serious cases, in that process, should be referred to the qualified professionals.

Mental health problems are growing at a rapid pace in India, being a cause of great concern in the healthcare space in India. It deserves to be treated like any other serious physical illness or disease, in a systematic way, backed by adequate budgetary support for affordable treatment and counselling measures, wherever required.

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.

With Highest Billionaire Wealth Concentration, India Tops Malnutrition Chart in South Asia: “What Future Do You Want?”

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Two recent global research reports, though on different spheres, place India at the top of the respective blocks. However, the take away messages that the studies offer are indeed poles apart in qualitative terms and worth pondering over collectively.

On January 20, 2014, just before the World Economic Forum (WEF) at Davos in Switzerland, Oxfam International released a report warning that by 2016, the world’s wealthiest 1 percent will control almost half of the global assets. Since 2009, the world’s billionaires have seen their share of the asset pie grow from 44 percent to 48 percent.

Before that, a World Bank Report of October 2014 titled, “Addressing Inequality in South Asia”, highlighted that India has the highest billionaire wealth concentration in South Asia.

Billionaire wealth to gross domestic product ratio in India was 12 percent in 2012. This was was higher than other economies with similar development level, namely, Vietnam with its ratio at less than two percent, and China with less than five percent.

This report also clarifies that inequality in South Asia appears to be moderate when looking at standard indicators such as the Gini index, which are based on consumption expenditures per capita. But other pieces of evidence reveal enormous gaps, from extravagant wealth at one end to lack of access to the most basic services at the other.

Stark realities: 

Wealth creation by no means is bad and in fact, is essential for economic growth of any nation, if read in isolation. This is mainly because, as the Oxfam report says, some economic inequality is essential to drive growth and progress, rewarding those with talent, hard earned skills, and the ambition to innovate and take entrepreneurial risks.

Unfortunately, at the same time, as the same World Bank report highlights, the stunted growth of children under fiver years of age, due to malnutrition, has been 60 percent of the total number of children born in the poorest households of India, as compared to 50 per cent in Bangladesh and Nepal.

Moreover, According to UNICEF, every year 1 million children again below the age of five years die due to malnutrition related causes in India. This number is worrisome as it is far higher than the emergency threshold, according to W.H.O classification of the severity of malnutrition.

Highlighting stark inequality in India, the report says, “The net worth of a household that is among the top 10 per cent can support its consumption for more than 23 years, while the net worth of a household in the bottom 10 per cent can support its consumption for less than three months.”

Some poor moved above the poverty line, though grossly inadequate:

According to the same report, from 2004-05 to 2009-10 when India’s GDP registered the highest ever average growth, about 40 percent of poor households moved above the poverty line and around 11 percent of poor population even moved into the middle class. Unfortunately, during the same period around 14 percent of the non-poor population also slipped below the poverty line.

Thus, what needs to be addressed soonest is the issue of vast difference in income between the richest and the poorest leading to an equally huge difference in the access to basic human developmental needs such as, education, healthcare and nutrition.

Adverse impact on expected ‘demographic dividend’ of India:

As legendary Bill Gates said in a recent media interview, “India has got far more kids that are malnourished and whose brains are not developed, way more than any other country. That’s really the crisis.”

If this trend of inequality continues, the ‘demographic dividend’ of India that the country has factored in so intimately in its future GDP growth narrative, could well be no more than a myth.

As US Supreme Court Justice Louis Brandeis once famously said, “We may have democracy, or we may have wealth concentrated in the hands of the few, but we cannot have both.”

The Oxfam report also emphasizes, the extreme levels of wealth concentration occurring today threaten to exclude hundreds of millions of people from realizing the benefits of their talents and hard work.

Social inequality and healthcare challenges:

Health of an individual is as much an integral contituent of the socio-economic factors as it is influenced by a person’s life style and genomic configurations. Important research studies indicate that socio-economic disparities, including the educational status, lead to huge disparity in the space of healthcare.

As stated in another report, ‘About 38 million people in India (which is more than Canada’s population) fall below the poverty line every year due to healthcare expenses, of which 70 percent is on purchase of drugs’.

Thus, reduction of social inequalities ultimately helps to effectively resolve many important healthcare issues. Otherwise, mostly the minority population with adequate access to knowledge, social and monetary power will continue to have necessary resources available to address their healthcare needs, appropriately.

Regular flow of newer and path breaking medicines to cure and effectively treat many diseases has not been able to eliminate either trivial or dreaded diseases alike. Otherwise, despite having effective curative therapy for malaria, typhoid, cholera, diarrhea/dysentery and venereal diseases, why will people still suffer from such illnesses? Similarly, despite having adequate preventive therapy, like vaccines for diphtheria, tuberculosis, hepatitis and measles, our children still suffer from such diseases. All these continue to happen mainly because of socio-economic inequalities related considerations, including poor level of awareness.

A paper titled, “Healthcare and equity in India”, published in The Lancet (February, 2011) identifies key challenges to equity in service delivery, healthcare financing and financial risk protection in India.

These include: 

- Imbalanced resource allocation

- Limited physical access to quality health services and inadequate human resources for health

- High out-of-pocket health expenditures

- High health spending inflation

- Behavioral factors that affect the demand for appropriate healthcare

Research studies vindicate the point:

Following are some research studies, which I am using just as examples to vindicate the above argument on inequality adversely impacting healthcare:

• HIV/AIDs initially struck people across the socio-economic divide. However, people from higher socio-economic strata responded more positively to the disease awareness campaign and at the same time more effective and expensive drugs started becoming available to treat the disease, which everybody cannot afford. As a result, HIV/AIDS are now more prevalent within the lower socio-economic strata of the society.

• Not very long ago, people across the socio-economic strata used to consume tobacco in many form. However, when tobacco smoking and chewing were medically established as causative factors for lung and oral cancers, those coming predominantly from higher/middle echelon of the society started giving up smoking and chewing of tobacco, as they accepted the medical rationale with their power of knowledge. Unfortunately the same has not happened with the poor people of lower socio-economic status. As a consequence of which, ‘Bidi’ smoking and ‘Gutka’/tobacco chewing have not come down significantly among the population belonging to such class, with more number of them falling victim of lung and oral cancers.

Thus, in future, to meet the unmet needs when more and more sophisticated and high cost disease treatment options will be available, mostly people with higher socio-economic background will be benefitted more due to their education, knowledge, social and monetary power. This widening socio-economic inequality will consequently widen the disparity in the healthcare scenario of the country.

Phelan and Link in their research study on this subject had articulated as under:

“Breakthroughs in medical science can do a lot to improve public health, but history has shown that, more often than not, information about and access to important new interventions are enjoyed primarily by people at the upper end of the socioeconomic ladder. As a result, the wealthy and powerful get healthier, and the gap widens between them and people who are poor and less powerful.”

Recent deliberations at Davos:

In the last two decades, socio-economic inequality in India has been fuelled by rapid, but unequal economic growth of the nation. Though the overall standard of living has been rising, there still remain a large number of populations living in pockets of intense deprivation and abject poverty.

One of the Davos sessions of this year deliberated on “What Future Do You Want?” The session, among others, reportedly felt the important need to ensure people’s well being and put in place effective measures such as a social safety net and universal healthcare.

At the same WEF annual meet at Davos, United Nation’s Secretary General Ban Ki-Moon also reiterated, “All policies must be people centric. We should make a world where nobody is left behind.”

Conclusion:

Assuming the above approach as a sincere realization of the current policy makers and more importantly the powerful influencers of those policies, the key question that comes up is: In which direction would India now chart its course to address this critical issue?

One may possibly hazard a guess on the shape of the future policies to come in India from the BJP party President Amit Shah’s recent address to crème de la crème of Mumbai businessmen in a function organized by a business news channel. In this event Mr. Shah reportedly said to them that the BJP does not agree with their definition of “reforms” and will strive to build a welfare state.

Will this approach of the new political dispensation get reflected in the forthcoming union budget as well, to effectively translate the new National Health Policy of India into reality, at least this time?

I deliberated on the National Health Policy of India in my Blog Post of January 12, 2015, titled “India’s National Health Policy 2015 Needs Wings To Fly”

That said, if it really so happens, a strong signal would go to all stakeholders that India is now well poised to chart on an uncharted frontier to significantly reduce the impact of inequality, particularly in the space of healthcare.

In that process, despite the highest billionaire wealth concentration, India would set a pragmatic course to place itself at the top of the healthcare chart, not just in South Asia, but probably also within the BRIC countries, to expect the least.

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 FDI Debate: Highly Opinionated, Sans Assessment of Tangible Outcomes?

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In 2001, the Government of India (GoI) allowed 100 percent Foreign Direct Investments (FDI) in the pharmaceutical sector through automatic route to attract more investments for new asset creation, boost R&D, new job creation and ultimately to help aligning Indian pharma with the modern pharma world in terms of capacity, capability, wherewithal, reach and value creation.

Thereafter, several major FDI followed, such as:

No. Company Acquirer Value US$M Year
1. Ranbaxy Daiichi Sankyo 4600 2008
2. Shantha Biotechnics Sanofi Pasteur 781 2009
3. Piramal Healthcare Abbott 3700 2010
4. Orchid Chemicals Hospira 200 2012
5. Agila Specialties Mylan 1850 2013

FDI started coming: 

Even recently, in April- June period of 2013, with a capital inflow of around US$ 1 billion, the pharma sector became the brightest star in otherwise gloomy FDI scenario of India.

However, out of 67 FDI investments till September 2011, only one was in the Greenfield area. It is now clear that the liberal pharma FDI policy is being predominantly used for taking overs the domestic pharma companies, as indicated earlier.

The Reserve Bank of India (RBI) data reveals that between April 2012 and April 2013, US$ 989 million FDI was received in brownfield investments, and just US$ 87.3 million in Greenfield investments.

As a result, in 2010 pharma Multi-National Corporations (MNCs) captured over 25 percent of the domestic Indian market, as against just around 15 percent in 2005.

An assessment thus far: 

While assessing the outcomes of liberal pharma FDI regime, especially at a time when India is seeking foreign investments in many other sectors, following facts surface:

New asset creation:

Most of the FDIs in pharma, during this period, have been substitution of domestic capital by foreign capital, rather than any significant new asset creation.

Investment in fixed assets (1994-95 to (2009-10):

Companies Rs. Crore Contribution %
Indian 54,010 94.7
MNC 3,022 5.3
Total 57,032 100

(Source: IPA)

Thus contrary to the expectations of GoI, there has been no significant increase in contribution in fixed assets by the pharma MNCs, despite liberalization of FDI.

Similarly, the available facts indicate that 100 percent FDI through automatic route in the pharma sector has not contributed in terms of creation of new modern production facilities, nor has it strengthened the R&D space of the country. The liberalized policy has not contributed to significantly increase in the employment generation by the pharma MNCs in those important areas, either.

The following figures would vindicate this point:

R&D Spend:

Companies 1994-95(Rs. Crore) Contribution % 2009-10(Rs. Crore) Contribution %
Indian 80.61 55.7 3,342.22 78.1
MNC 64.13 44.3 934.40 21.9
Total 144.74 100 4,276.32 100

(Source: IPA)

The above table vindicates that post liberalization of FDI regime, MNC contribution % in R&D instead of showing any increase, has significantly gone down.

Wage Bill/ Job Creation:

Companies 1994-95(Rs. Crore) Contribution % 2009-10(Rs. Crore) Contribution %
Indian 664 65.5 8,172 87.1
MNC 350 34.5 1,215 12.9
Total 1,014 100 9,387 100

(Source: CMIE)

In the area of job creation/wage bills, as well, liberalized FDI has not shown any increasing trend in terms of contribution % in favor of the MNCs.

Delay in launch of cheaper generics:

There are instances that the acquired entity was not allowed to use flexibilities such as patent challenges to introduce new affordable generic medicines.

The withdrawal of all patent challenges by Ranbaxy on Pfizer’s blockbuster medicine Lipitor filed in more than eight countries immediately after its acquisition by Daiichi-Sankyo, is a case in point.

Key concerns expressed:

Brownfield acquisitions seem to have affected the entire pharma spectrum, spanning across manufacturing/ marketing of oral formulations; injectibles; specialized oncology verticals; vaccines; consumables and devices, with no tangible perceptible benefits noted just yet.

Concerns have been expressed about some sectors, which are very sensitive, such as, cancer injectibles and vaccines.

Moreover, domestic Indian pharma exports generic medicines worth around US$ 13 billion every year establishing itself as a major pharmaceutical exporter of the world and is currently the net foreign exchange earner for the country. If the Government allows the domestic manufacturing facilities of strategic importance to be taken over by the MNCs, some experts feel, it would adversely impact the pharmaceutical export turnover of the country, besides compromising with the domestic capacity while facing epidemics, if any or other health exigencies. It would also have a negative fall out on the supply of affordable generic medicines to other developing nations across the world.

Countries such as Brazil and Thailand have a robust public sector in the pharma space. Therefore, their concerns are less. Since India doesn’t have a robust public sector to fall back on, many experts feel that unrestrained acquisitions in the brownfield sector could be a serious public health concern.

Some conditions proposed:

The DIPP proposal reportedly wants to make certain conditions mandatory for the company attracting FDI, such as:

  • If a company manufactures any of the 348 essential drugs featuring in the National List of Essential Medicines (NLEM), the highest level of production of that drug in the last three years should be maintained for the next five years
  • The acquirer foreign company would not be allowed to close down the existing R&D centres and would require to mandatorily invest upto 25 per cent of the FDI in the new unit or R&D facility. The total investment as per the proposed condition would have to be incurred within 3 years of the acquisition.
  • Reduction of FDI cap to 49 per cent in rare or critical pharma verticals, as discussed above.
  • If there is any transfer of technology it must be immediately communicated to the administrative ministries and FIPB

Vaccines and cancer injectibles, which have a limited number of suppliers, could fall under the purview of even greater scrutiny.

Conclusion: 

The Ministries of Health and Commerce & Industries, which are in favor of restricting FDI in pharma stricter, are now facing stiff opposition from the Finance Ministry and the Planning Commission.

The Department of Industrial Policy and Promotion (DIPP) has now repotedly prepared a draft Cabinet Note after consulting the ministries of Finance, Pharma and Health, besides others. However, as comments from some ministries came rather late, the DIPP is reportedly moving a supplementary note on this subject.

The matter is likely to come up before the cabinet by end November/December 2013.

While FDI in pharma is much desirable, it is equally important to ensure that a right balance is maintained in India, where majority of the populations face a humongous challenge concerning access to affordable healthcare in general and affordable medicines in particular.

There is, therefore, an urgent need for critical assessment of tangible outcomes of all pharma FDIs in India as on date, based on meaningful parameters. This would help the Government while taking the final decision, either in favor of continuing with the liberalized FDI policy or modifying it as required, for the best interest of country.

Otherwise, without putting the hard facts, generated from India, on the table, is it not becoming yet another highly opinionated debate in its ilk, between  the mighty MNC pharma lobby groups either directly or indirectly, the Government albeit in discordant voices and other members of the society?

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.

Vaccines Development: Is it Just a Business Based on Fear?

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‘Vaccination – A Business based on fear’, is the title of a book written by Dr. Gerhard Buchwald M.D, a German medical doctor and a vaccination critic. This book talks about:

“The damage and the deaths caused by vaccination are written off as ‘pure coincidence’, as something which would have occurred anyway, even without vaccination. Often damage is trivialized by claiming that vaccine damage occurs only very, very rarely, or the damage is covered up by naming as the cause, the most unlikely syndromes which can only be found in special literature.”

However, his critics and pro-vaccination experts do opine that this book “is a pathetic presentation of vaccination, from a self-proclaimed anti-vaccination lobbyist. It is full of half-truths, blatant lies and misrepresented statistics”.

Vaccination – one of the most important development in medicines: 

Quite in contrary to what Dr. Gerhard Buchwald wrote, vaccination was voted as one of the four most important developments in medicine of the past 150 years, alongside sanitation, antibiotics and anesthesia by readers of the ‘British Medical Journal’ in 2007. No wonder, Vaccines are one of the most successful and cost-effective public health interventions, which help preventing over 3 million deaths every year throughout the world topping the list in terms of lives saved.

Vaccines that are being developed and marketed today, though provide high level of protection against increasing number of diseases with reduction of associated morbidity and mortality, there is still a crying need for greater encouragement, more resource deployment and sharper focus towards newer vaccines development for many more dreaded and difficult diseases.

In tandem, concerted efforts need to be made by both the industry and the government to improve affordable access to all these vaccines for a larger section of the population, especially in the developing world.

Rejuvenating trend:

However, from the business perspective, the vaccine market, though initially considered to be a low-profit initiative, now has started being under rejuvenated focus keeping pace with improved understanding of the human immune system. The future scope of vaccines is immense, as the management of several potentially preventable diseases remains still unaddressed.

Consequently, the focus of the global vaccine industry is getting expanded from prophylactic vaccination for communicable disease (e.g. DTP vaccine) to therapeutic vaccines (e.g. Anti-cancer vaccines) and then possibly non-communicable disease vaccines (e.g. vaccines for coronary artery disease).

Shifting focus on vaccines types:

As per the ‘National Institute of Health (NIH)’ of USA, following are some types of vaccines that researchers usually work on:

  • Live, attenuated vaccines
  • Inactivated vaccines
  • Subunit vaccines
  • Toxoid vaccines
  • Conjugate vaccines
  • DNA vaccines
  • Recombinant vector vaccines

Among all these segments, sub-unit vaccine is the largest revenue generator, though synthetic vaccines, recombinant vector vaccines, and DNA vaccines are emerging as the fastest-growing segments.

The first vaccine of the world:

In 1796, Edward Anthony Jenner not only discovered the process of vaccination, alongside developed the first vaccine of the world for mankind – smallpox vaccine. To develop this vaccine Jenner acted upon the observation that milkmaids who caught the cowpox virus did not catch smallpox.

As per published data prior to his discovery the mortality rate for smallpox was as high as up to 35%. Thus, Jenner is very often referred to as the “Father of Immunology”, whose pioneering work has “saved more lives than the work of any other person.”

Later on in 1901 Emil Von Behring received the first Nobel Prize (ever) for discovering Diphtheria serum therapy.

R&D costs for vaccines:

According to a paper published by the US National Library of Medicine and National Institute of Health (NIH):

“A vaccine candidate entering pre-clinical development in 2011 would be expected to achieve licensure in 2022; all costs are reported in 2022 Canadian dollars (CAD). After applying a 9% cost of capital, the capitalized total R&D expenditure amounts to $ 474.88 million CAD.”

Issues and challenges:

To produce a safe and effective marketable vaccine, besides R&D costs, it takes reportedly around 12 to 15 years of painstaking research and development process.

Moreover, one will need to realize that the actual cost of vaccines will always go much beyond their R&D expenses. This is mainly because of dedicated and highly specialized manufacturing facilities required for mass-scale production of vaccines and then for the distribution of the same mostly using cold-chains.

Around 60% of the production costs for vaccines are fixed in nature (National Health Policy Forum. 25. January 2006:14). Thus such products will need to have a decent market size to be profitable.

Unlike many other medications for chronic ailments, which need to be taken for a long duration, vaccines are administered for a limited number of times, restricting their business potential.

Thus, the long lead time required for the ‘mind to market’ process for vaccine development together with high cost involved in their clinical trials/marketing approval process, special bulk/institutional purchase price and limited demand through retail outlets, restrict the research and development initiatives for vaccines, unlike many other pharmaceutical products.

Besides, even the newer vaccines will mostly be required for the diseases of the poor, like Malaria, Tuberculosis, HIV and ‘Non Communicable Diseases (NCDs)’ in the developing countries, which may not necessarily guarantee a decent return on investments for vaccines, unlike many other newer drugs. As a result, the key issue for developing a right type of newer vaccine will continue to be a matter of pure economics.

A great initiative called GAVI: 

Around 23 million children of the developing countries are still denied of important and life-saving vaccines, which otherwise come rather easily to the children of the developed nations of the world.

To resolve this inequity, in January 2000, the Global Alliance for Vaccines and Immunization (GAVI) was formed. This initiative was mainly aimed at generating sufficient fund to ensure availability of vaccines for children living in the 70 poorest countries of the world.

The GAVI Alliance has been instrumental in improving access to six common infant vaccines, including those for hepatitis B and yellow fever. GAVI is also working to introduce pneumococcal, rotavirus, human papilloma virus, meningococcal, rubella and typhoid vaccines in not too distant future.

In August 2013, GAVI has reportedly launched a campaign in Kenya to fight the world’s leading killer of children under five with a new Pneumococcal Vaccine for prevention from pneumonia, meningitis and sepsis, which kill more than half a million people a year.

GAVI hopes to avert 700,000 deaths by 2015 through the immunization of 90 million children with pneumococcal vaccines.

Global pharma majors Pfizer and GlaxoSmithKline (GSK) are producing the vaccines as a part of a deal part-funded by Britain, Italy, Canada, Russia, Norway and the Bill Melinda Gates Foundation.

Current trend in newer vaccine development:

Malaria Vaccine:

According to the National Institute of Health (NIH) of the United States, the results of an early-stage clinical trial published in August 8, 2013 in the ‘Journal Science’ for an investigational malaria vaccine has been found to be safe to generate an immune system response and to offer protection against malaria infection in healthy adults.

The scientists at Sanaria Inc., of Rockville, Md. Research Center developed this vaccine known as PfSPZ. The researchers reportedly found that injecting patients with live-but-weakened malaria causing parasites appeared to create a protective effect.

Earlier, Reuters on December 20, 2011 reported that the British scientists have developed an experimental malaria vaccine, which has the potential to neutralize all strains of the most deadly species of malaria parasite.

In October 2011, the data published for a large clinical trial conducted in Africa by GlaxoSmithKline on their experimental malaria vaccine revealed that the risk of children getting malaria had halved with this vaccine. Reuters also reported that other teams of researchers around the world are now working on different approaches to develop a malaria vaccine.

Tuberculosis vaccines:

The Lancet reported in March 2013, as BCG vaccination provides incomplete protection against tuberculosis in infants, a new vaccine, modified Vaccinia Ankara virus expressing antigen 85A (MVA85A), has been designed to enhance the protective efficacy of BCG. MVA85A was found well-tolerated and induced modest cell-mediated immune responses. However, the reasons for the absence of MVA85A efficacy against tuberculosis or M tuberculosis infection in infants would need exploration.

Universal Cancer vaccines:

In a breakthrough development, the Israeli company Vaxil BioTherapeutics has reportedly formulated a therapeutic cancer vaccine, now in clinical trials at Hadassah University Medical Center in Jerusalem.

If everything falls in place, the vaccine could be available about six years down the road, to administer on a regular basis not only to help treating cancer but also to keep the disease from recurring.

Though the vaccine is being tested against a type of blood cancer called multiple myeloma, if it works as the initial results indicate, its platform technology VaxHit could be applied to 90 percent of all known cancers, including prostate and breast cancer, solid and non-solid tumors.

HIV Vaccine:

A recent effort to find a vaccine for HIV is reportedly beginning in 2013 at laboratories in a London hospital and two centers in Africa. The work will be split equally between London, the Rwandan capital Kigali and Nairobi in Kenya.

It has been reported that scientists are recruiting 64 healthy adult volunteers for the trial, which is expected to take up to two years.

Vaccines requirements of the developing world: 

Developing countries of the world are now demanding more of those vaccines, which no longer feature in the immunization schedules of the developed nations. Thus to supply these vaccines at low cost will be a challenge, especially for the global vaccine manufacturers, unless the low margins get well compensated by high institutional demand.

India needs a vibrant vaccine business sector:

For greater focus on all important disease prevention initiatives, there is a need to build a vibrant vaccine business sector in India. To achieve this objective the government should create an enabling ecosystem for the vaccine manufacturers and the academics to work in unison. At the same time, the state funded vaccine R&D centers should be encouraged to concentrate more on the relevant vaccine development projects ensuring a decent return on their investments, for longer-term economic sustainability.

More often than not, these stakeholders find it difficult to deploy sufficient fund to take their vaccines projects successfully through various stages of clinical development in order to obtain marketing approval from the drug regulator, while registering a decent return on investments. This critical issue needs to be appropriately and urgently addressed by the Government to make the disease prevention initiatives in the country sustainable.

Changing market dynamics: 

Even in a couple of decades back, ‘Vaccines Market’ in India did not use to be considered as a focus area by many pharmaceutical companies. Commoditization of this market with low profit margin and unpredictable interest of the government/the doctors towards immunization were the main reasons. Large global players like Glaxo exited the vaccine market at that time by withdrawing products like, Tetanus Toxoid, Triple Antigen and other vaccines from the market.

Currently, the above scenario is fast changing. The vaccine market, as stated above, is getting rejuvenated not only with the National Immunization Program (NIP) of the country, but also with the emergence of newer domestic vaccines players and introduction of novel vaccines by the global players, which we shall discuss below.

In addition, the ‘Indian Academy of Pediatrics (IAP) Committee on Immunization’ now recommends the ‘best individual practices schedule’ for the children in consultation with their respective parents. Such schedule may not conform to NIP and include newer vaccines, broadening the scope of use of vaccines in general.

Global Market:

According to GBI Research Report, overall global vaccines market was valued at US$ 28 billion in 2010 and is expected to reach US$ 56.7 billion by 2017 with a CAGR of 11.5%. The key growth driver of this segment will be introduction of newer vaccines, which are currently either in the regulatory filing stage or in the late stages of clinical development.

The important international players in the vaccines market are GlaxoSmithKline, Sanofi, Pfizer, Novartis AG, Merck and SP-MSD. Together they represent around 88% of the total vaccine segment globally, the report highlights.

Indian Market:

McKinsey in its report titled, “India Pharma 2020: Propelling access and acceptance, realizing true potential“ stated that at 2% penetration, the vaccines market of India is significantly under-penetrated with an estimated turnover of around US$ 250 million, where the private segment accounts for two-thirds of the total. McKinsey expects the market to grow to US$ 1.7 billion by 2020.

India is one of largest markets for all types of vaccines in the world. The new generation and combination vaccines, like DPT with Hepatitis B, Hepatitis A and Injectable polio vaccine, are driving the growth. The demand for veterinary vaccines is also showing ascending trend. Pediatric vaccines contribute to around 60% of the total vaccines market in India.

Domestic Indian players like, Serum Institute, Shantha Biotecnics, Bharat Biotech and Panacea Biotech are poised to take greater strides in this direction. Bharat Biotech is incidentally the largest Hepatitis B vaccine producer in the world. Likewise, Serum Institute is reportedly one of the largest suppliers of vaccines to over 130 countries and claim that ’1 out of every 2 children immunized worldwide gets at least one vaccine produced by Serum Institute.’

The first new vaccine developed in India:

Indian scientists from Bharat Biotech Ltd in Hyderabad have reportedly developed a new oral vaccine against the Rotavirus induced diarrhea, where both vomiting and loose motion can severely dehydrate children very quickly. This is the first new vaccine developed in India, establishing itself as the first developing country to achieve this unique distinction.

Two recent vaccine JV and Partnership agreements in India:

British drug major GlaxoSmithKline (GSK) has reportedly agreed to form a 50-50 venture with the domestic Indian vaccine manufacturer Biological E Limited in January 2013 to develop a product that would combine GSK’s injectable polio shot with a vaccine produced by Biological E to protect against five diseases including diphtheria and tetanus.

In addition, MSD pharma of the United States and Indian drug major Lupin have announced a partnership agreement to market, promote and distribute, MSD’s 23-valent Pneumococcal Polysaccharide Vaccines under a different brand name in India for prevention of Pneumococcal disease, pneumonia being its most common form affecting adults.

A possible threat: 

As per reports most Indian vaccines manufacturers get a major chunk of their sales revenue from exports to UN agencies, charitable organizations like, the Bill & Melinda Gates Foundation and GAVI, and other country-specific immunization programs.

The report predicts, the virtual monopoly that Indian vaccines manufacturers have enjoyed in these areas, will now be challenged by China, as for the first time, in 2012, the Chinese national regulatory authority received World Health Organization’s (WHO) ‘pre-qualification’ certification that allows it to approve locally manufactured vaccines to compete for UN tenders. 

Action areas to drive growth:

McKinsey in its above report ‘India Pharma 2020’ indicated that the action in the following 4 areas by the vaccine players would drive the vaccine market growth in India:

  • Companies need to go for local production of vaccines or leverage supply partnerships. MSD and GlaxoSmithKline’s local partnership in India and for the HiB vaccine with Bio-manguinhos in Brazil may be cited as examples.
  • Companies will need to conduct studies on the economic impact of vaccination and establish vaccine safety and performance standards.
  • Extension of vaccine coverage beyond pediatricians and inclusion of general practitioners, consulting physicians and gynecologists will be essential.
  • Companies will need to enhance supply chain reliability and reduce costs.

Conclusion: 

On January 7, 2012, while requesting the ‘Overseas Indian Medical Professionals’ to partner with the institutions in India, the Health Minister, in his address, announced that the Ministry of Health has already introduced the second dose of measles vaccine and Hepatitis-B vaccination across the country. Moreover, from December 2011 a ‘Pentavalent Vaccine’ has been introduced, initially in 2 States, covering 1.5 million children of India.

All these augur quite well for the country. However, keeping in view of the humongous disease burden of India, immunization program with various types of vaccines should receive active encouragement from the government as disease prevention initiatives, keeping the future generation in mind.

If vaccine related pragmatic policy measures, with equal focus on their effective implementation, are initiated in the country, without delay, the domestic vaccine market, in turn, will receive much awaited further growth momentum. Such initiatives together with newer foreign players and modern imported vaccines coming in, would help the country addressing effectively a prime healthcare concern of the country in a holistic way.

It is about time to aggressively garner adequate resources to develop more modern vaccines in the country, promote and implement vaccine awareness campaigns in the nation’s endeavor for disease prevention before they strike hard and at times fatally.

That said, taking available real world facts into account, doesn’t Dr. Gerhard Buchwald’s and today’s anti-vaccination lobbyists’ postulation, ‘Vaccination – A Business based on fear’, appear to be emanating from a self created world of doom and gloom, defying public health interest for effective disease prevention?

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.

 

Quick implementation of the undiluted ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

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Many industry experts after having evaluated the provisions of the original draft proposal for forming a Central Drugs Authority (CDA) in the country, commended and supported this laudable initiative of the Government. This Bill also known as, “The Drugs & Cosmetics (Amendment) Bill No.LVII of 2007 to amend the Drugs & Cosmetics Act, 1940” was introduced in the ‘Rajya Sabha’ on August 21 2007 and was thereafter referred to ‘The Parliamentary Standing Committee of Health and Family Welfare’ for review. The Committee also has submitted its recommendations to the Government since quite some time. However, the fact still remains that the proposed CDA Bill has not seen the light of the day, as yet.
Mashelkar Committee Recommendation:
It is high time to consider the recommendations of Dr. R.A. Mashelkar Committee on the subject and make amendments in Act to facilitate creation of a Central Drugs Authority (CDA) and introduce centralized licensing for manufacturing for sale, export and distribution of drugs.
Seven reasons for the dire need of the CDA in India:
I firmly believe that the formation of the ‘Central Drugs Authority (CDA)’ will provide the following benefits to the Industry and also the Government:
1. Achieving uniform interpretation of the provisions of the Drugs & Cosmetics Act & Rules
2. Standardizing procedures and systems for drug control across the country
3. Enabling coordinated nationwide action against spurious and substandard drugs
4. Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India
5. Implementing uniform enforcement action for banned and irrational drugs
6. Creating a pan-Indian approach to drug control and administration
7. Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.
Major countries have similar set up even within a federal system:
All major countries of the world have a strong federal drug control and administration system in place for the Pharmaceutical Industry. Like for example, despite strongly independent states within the federal structure of the U.S., the US – FDA is a unified and fully empowered federal government entity.
Similarly, coming together of many independent countries in Europe had led to the need for a pan-European drug control agency. This responsibility was vested on to the ‘European Medicine Agency (EMEA)’ with overriding pan-European authority and powers within the European Union (EU).
Thus, a single Central Authority that administers and regulates both pharmaceutical manufacturing and research is an absolute necessity in India’s bid to be a global hub for drug discovery.
The interim measure:
In my view, till CDA is formed, registration and marketing authorization for all new drugs and fixed-dose combinations should only be granted by Drugs Controller General of India (DCGI). I would emphasize, it is essential that a smooth transition takes place from the existing regulatory environment to the proposed CDA, carefully tightening all the loose knots in the process. All necessary infrastructures along with the required personnel must be in place, so that all permissions are granted to applicants within stipulated timeframe.
The watershed regulatory reform initiative should not get diluted:
The CDA Bill is widely considered as a watershed regulatory reform initiative in the pharmaceuticals space of India. This reform process, besides offering all other benefits as discussed above, would also be able  to update the legislation, considering significant advances the country has made since the last five decades, especially in the areas of clinical research, treatment methods, and sophisticated diagnostic and medical devices.
Conclusion:
It now appears, the Government could revive the CDA Bill and reintroduce it in the Parliament, sooner. It was to be introduced in its monsoon session. However, the plan did not fructify, as the Parliament could not function due to a logjam created by our politicians.
It is worth noting that the proposed centralize drug licensing mechanism was vehemently opposed by the state drug authorities and some section of the industry. The stated position of the opponents to the CDA Bill apprehends that the centralized structure will not be able to deliver, as the requisite infrastructure and manpower for the same are not in place, as yet.
This development bring out to the fore the lurking fear that the proposal to centralize drug licensing as a part of the proposed law, very unfortunately, may eventually get quite diluted because of vested interests.

By: Tapan J Ray

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

Quick implementation of the UNDILUTED ‘Central Drug Authority (CDA)’ Bill is essential for emerging India

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Many industry experts after having carefully evaluated the provisions of the original draft of the proposal of forming a CDA in the country commended and supported this praiseworthy initiative of the Government. This Bill also known as, “The Drugs & Cosmetics (Amendment) Bill No.LVII of 2007 to amend the Drugs & Cosmetics Act, 1940” was introduced in the ‘Rajya Sabha’ on August 21 2007 and was thereafter referred to ‘The Parliamentary Standing Committee of Health and Family Welfare’ for review. The Committee also has submitted its recommendations to the Government since quite some time. However, the fact still remains that the proposed CDA Bill has not seen the light of the day, as yet.

Mashelkar Committee Recommendation:

It is high time to consider the recommendations of Dr. R. A. Mashelkar Committee on the subject and make amendments in the Act to facilitate the creation of a Central Drugs Authority (CDA) and introduce centralized licensing for the manufacture for sale, export or distribution of drugs.

Seven reasons for the dire need of the CDA in India:

I firmly believe that the formation of the ‘Central Drugs Authority (CDA)’ will provide the following seven significant benefits to the Industry and also to the Government:

 1.    Achieving uniform interpretation of the provisions of the Drugs &  Cosmetics Act & Rules

 2.    Standardizing procedures and systems for drug control across the country

3.    Enabling coordinated nationwide action against spurious and substandard drugs

4.    Upholding uniform quality standards with respect to exports to foreign countries from anywhere in India

 5.    Implementing uniform enforcement action in case of banned and irrational drugs

 6.    Creating a pan-Indian approach to drug control and administration

7.    Evolving a single-window system for pharmaceutical manufacturing and research undertaken anywhere in the country.

Major countries have similar set up even within a federal system:

All major countries of the world have a strong federal drug control and administration system in place for the Pharmaceutical Industry. Like for example, despite strongly independent states within the federal structure of the U.S., the US – FDA is a unified and fully empowered federal government entity. 

Similarly, the coming together of many independent countries in Europe has led to the need for a pan-European drug control agency and that responsibility has been vested on the ‘European Medicine Agency (EMEA)’ which has overriding pan-European powers, that is within the European Union (EU).

Thus, a single Central Authority that administers and regulates both pharmaceutical manufacturing and pharmaceutical research is an absolute necessity in India’s bid to be a global hub for drug discovery.

The interim measure:

In my view, till CDA is formed, registration and marketing authorization for all new drugs and fixed-dose combinations should only be granted by Drugs Controller General of India (DCGI).  I would like to emphasize, it is essential that there a smooth transition takes place from the existing regulatory environment to the proposed CDA, carefully tightening all the loose knots in the process. All necessary infrastructures along with the required personnel must be in place so that all permissions are granted to applicants within stipulated time frame.

The watershed regulatory reform initiative should not go waste:

Thus the CDA Bill is considered to be a watershed regulatory reform initiative in the pharmaceuticals space of India. This reform, besides all others as discussed above, would have updated the legislation considering the advances the country has made, especially, in the last five decades in clinical research, treatment methods, and sophisticated diagnostic and medical devices.

Conclusion:

It now appears that the Government could revive the CDA Bill and reintroduce in the Parliament. It was to be introduced in its monsoon session. However, the plan did not fructify because of various political reasons.

Centralize drug licensing has also been highly opposed by the state drug authorities and some section of the industry. The stated position of these opponents to the CDA Bill highlights that the proposed centralized structure will not be able to deliver as the requisite infrastructure for the same is not in place, as yet.

All these developments bring out the apprehension that the proposal to centralize drug licensing as part of the proposed law, very unfortunately, may get quite diluted because of vested interests.

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.