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Dynamics of Cancer Therapy Segment Remain Enigmatic

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Currently, cancer is likely to occupy the center stage on any discussion related to the fastest growing therapy segments in the pharma or biotech industries. There are several reasons behind such probability, some of which include:

  • Cancer is not only the second leading cause of death globally, but also offer outstanding new drug treatment options, though, mostly to those who can afford.
  • Consequently, these drugs are in high demand for saving lives, but not accessible to a vast majority of those who need them the most.
  • Alongside, oncology is one of the fastest growing therapy segments in sales in many countries, including the largest and most attractive global pharma market - the United States.
  • New cancer drugs being complex, involves highly sophisticated cutting-edge technology – creating an entry barrier for many, and are generally high priced, fetching a lucrative profit margin.

These are only a few basic dynamics of the segment. Nevertheless, understanding these dynamics, in a holistic way, is indeed an enigma – caused mostly by directly conflicting arguments on many related issues, within the key stakeholders. Thus, I reckon, this issue will be an interesting area to explore in this article. Later in this discussion, I shall try to substantiate all the points raised, backed by credible data. Let me start with some causative factors, that may make comprehensive understanding of the dynamics of this segment enigmatic.

Some causative factors for triggering the enigma:

Close overlap of several contentious factors is associated with this head-scratcher. These come in a package of reasoning and counter reasoning, a few examples of which may be seen below:

  • When increasing incidence of cancer related deaths are a global problem, fast growing oncology segment, regularly adding novel drugs in its portfolio, ideally should be a signal for containing this problem. Whereas, the World Health Organization (W.H.O) reports, cancer drugs are beyond reach to millions, for high cost. Nonetheless, the cancer drug sales keep shooting north.
  • Nearer home, while Indian anti-cancer drug market growth has, reportedly, ‘outstripped that of all other leading countries in recent years and is set to go on doing so,’ another study report underscores, ‘Indians have poor access to essential anti-cancer drugs.’
  • Although, a 2019 report of W.H.O highlights: Expensive cancer drugs ‘impairing’ access to cure, innovator companies also have their counter argument ready. They claim, higher prices ‘are necessary to fund expensive research projects to generate new drugs.’
  • When innovator companies keep touting that many new therapies are path-breaking concepts, researchers don’t find these drugs much superior to the existing ones in outcomes, except jaw-dropping prices.
  • Despite the above argument of research-based drug players to justify unreasonable pricing, several studies have established that the development cost of new cancer drugs is more than recouped in a short period, and some companies are making even more than a 10-fold higher revenue than R&D spending.
  • While several pharma companies claim that they are providing patients with access to a wide variety of cancer medication through Patient Assistance Programs (PAPs), the findings of several published research on the same concluded, ‘the extent to which these programs provide a safety net to patients is poorly understood.’

Let me now briefly substantiate each of the above points raised in this article.

Incidence of cancer and the oncology market:

Now, while substantiating the above points, let me go back to where I started from. According to the W.H.O fact sheet of September 12, 2018, cancer is the second leading cause of death globally and is responsible for an estimated 9.6 million deaths in 2018 – about 1 in 6 deaths was due to cancer. Approximately 70 percent of deaths from cancer occur in low- and middle-income countries. The Indian Council for Medical Research (ICMR) estimated around 1.4 million new cancer cases in 2016, which is expected to rise to 1.7 million cases by 2020.

According to ‘World Preview 2019, Outlook to 2024’ of Evaluate Pharma, ‘Oncology prevails as the leading therapy segment in 2024, with a 19.4 percent market share and sales reaching USD 237bn.’ The report also highlights: ‘Oncology is the area with the largest proportion of clinical development spending with 40 percent of total pipeline expenditure.’

Similarly, the Indian Oncology market is found to be growing at 20 percent every year and is likely to remain so for the coming 3-5years. In 2012 the cancer market was valued at USD 172m (quoted from Frost & Sullivan). Another report also reiterates, the oncology market in India has outstripped that of all other leading countries in recent years and is set to go on doing so.

Poor access to cancer drugs:

Despite the impressive growth of oncology segment, ‘high prices for cancer medicines are “impairing the capacity of health care systems to provide affordable, population wide access,” emphasizes a recent ‘Technical Report’ of W.H.O. I shall further elaborate on this report in just a bit. However, before that, let me cite an India specific example of the same. The March 2019 study, published in the BMJ Global Health, also highlighted, the mean availability of essential anti-cancer medicines across all hospitals and pharmacies surveyed in India was less than the WHO’s target of 80 percent.

Cancer drug pricing conundrum:

The recent ‘Technical Report of W.H.O – ‘Pricing of cancer medicines and its impacts’ confronts this issue head on. It clearly articulates, the enduring debates on the unaffordability of cancer medicines and the ever-growing list of medicines and combination therapies with annual costs in the hundreds of thousands, suggests that the status quo is not acceptable. The global community must find a way to correct the irrational behaviors that have led to unsustainable prices of cancer medicines. Thus, correction of unaffordable prices is fundamental to the sustainability of access to cancer medicines. Further inertia on this issue and half-hearted commitments from all stakeholders, including governments and the pharmaceutical industry, will only invite distrust and disengagement from the public, the report emphasized.

Another 2019 WHO report says expensive cancer drugs ‘impairing’ access to cure. It pinpointed: “Pharmaceutical companies set prices according to their commercial goals, with a focus on extracting the maximum amount that a buyer is willing to pay for a medicine.” It also reiterated that the standard treatment for breast cancer can drain 10 years of average annual income in India. Unaffordable pricing of cancer medicines set by such intent often prevents their full benefits being realized by scores of cancer patients, the report adds. Yet another paper expressed similar concern about ‘the unsustainability of the high costs of cancer care, and how that affects not only individual patients, but also society at large.

What does the industry say?

The industry holds a different view altogether. According to another recent news, one such company quoted their 2017 Janssen U.S. Transparency Report,” which states: “We have an obligation to ensure that the sale of our medicines provides us with the resources necessary to invest in future research and development.” This is interesting, as it means that even higher pricing may be necessary to fund expensive research projects to generate new drugs for life threatening ailments, such as cancer.

What do research studies reveal?

There are several research studies often disputing the industry quoted claim of R&D spend of over a couple of billion dollar to bring a new molecule to the market. They also keep repeating, this is an arduous and time-intensive process, involving humongous financial risk of failure. One such ‘Original investigation’ titled, ‘Research and Development Spending to Bring a Single Cancer Drug to Market and Revenues After Approval,’ published by JAMA Internal Medicine in its November 2017 issue, presents some interesting facts.

The study brings to the fore: ‘The cost to develop a cancer drug is USD 648.0 million, a figure significantly lower than prior estimates. The revenue since approval is substantial (median, USD 1658.4 million; range, USD 204.1 million to USD 22 275.0 million). This analysis provides a transparent estimate of R&D spending on cancer drugs and has implications for the current debate on drug pricing.’ Thus, the cost of new cancer drug development is more than recovered in a short period, with as much as over 10-fold higher revenue than R&D spending, in many cases, as the analysis concluded.

Even top oncologists, such as Dr. Peter Bach, the Director of Memorial Sloan Kettering’s (MSK)Center for Health Policy and Outcomes, along with other physicians at MSK drew attention to the high price of a newly approved cancer drug. According to available reports, ‘two recently approved CAR-T cell drugs – one is USD 373,000 for a single dose, the other USD 475,000 - are benchmarks on the road to ever-higher cancer drug price tags.’

It happens in India too:

Although, on May 19, 2019, NPPA announced almost 90 percent price reduction of nine anti-cancer drugs, curiously even those cancer drugs, which are not patent protected, continued to be sold at a high price. For example, according to the September 2018 Working Paper Series, of the Indian Institute of management Calcutta (IIM C), the maximum price for Pemetrexed, a ‘not patented’ cancer product was Rs 73,660, though, it is also available at Rs 4,500. Similarly, the price of Bortezomib was between Rs 60,360 and Rs 12,500 and Paclitaxel between Rs 19, 825.57 and Rs 7,380.95. It is intriguing to note that no pricing policy for patented drugs, as promised in the current Drug Policy document, hasn’t been implemented, as yet. 

Does Pharma’s ‘Patient Assistance Programs (PAPs) work? 

Different pharma companies claim their addressing access to cancer care in developing countries. A report also mentions: ‘16 of the world’s largest pharmaceutical companies are engaged in 129 diverse access initiatives in low- and middle-income countries.’ Whereas, a research study, questioning the transparency of these initiatives, concluded, ‘our results suggest that numerous drug company sponsored PAPs exist to provide patients with access to a wide variety of medications but that many details about these programs remain unclear. As a result, the extent to which these programs provide a safety net to patients is poorly understood.’

During the famous Glivec patent case, which went against Novartis at the Supreme Court of India, the company’s PAP for Glivec in the country, also came under focus. Many articles, with mutually conflicting views of the company and independent experts were published regarding this program. One such write-up emphasized with eulogy, “Novartis provides Glivec free of charge to 16,000 patients in India, roughly 95 percent of those who need it via the Novartis – Glivec International Patient Assistance Program. The remaining 5 percent is either reimbursed, insured, or participate in a very generous co-payment program. Thus, not granting a patent for Glivec really hasn’t prevented patients from getting this life-saving medication.”

However, many were, reportedly, not convinced by Novartis’ claims and counter-argued: “Our calculation says there are estimated 20,000 new patients every year suffering from cancer, this means after ten years there will be two lakh (200,000) patients, hence the program is not enough.” The views of many independent global experts on the same are not very different. For example, even Professor Carlos M. Correa had articulated: “The reported donation of Glivec by Novartis to ‘eligible patients’ under the ‘Glivec International Patient Assistance Program’ (GIPAP) may be a palliative but does not ensure a sustainable supply of the product to those in need.” Be that as it may, new studies now question whether novel anti-cancer drugs are worth their extra cost.

Are novel cancer drugs worth the extra cost?

According to a September 26, 2019 report, the results of two studies investigating the links between clinical benefit and pricing in Europe and the USA, reported at the European Society for Medical Oncology (ESMO) Congress, September 2019, reveal an interesting finding. It found, many new anti-cancer medicines add little value for patients compared to standard treatment and are rarely worth the extra cost. Interestingly, in the midst of this imbroglio, the world continues taking a vow globally to mitigate the cancer patient related issues on February the fourth, every year.

A vow is taken globally on every 4th February, but…:

On every February 04 – The World Cancer Day - an initiative of the Union for International Cancer Control (UICC), the world takes a noble vow. Everybody agrees on its broad goal that: ‘Life-saving cancer diagnosis and treatment should be equal for all – no matter who you are, your level of education, level of income or where you live in the world. By closing the equity gap, we can save millions of lives.’

UICC also noted, as many cancers are now preventable or can be cured, more and more people are surviving the disease. However, for the vast majority people, the chances of surviving cancer are not getting better. Socioeconomic status of individuals leaves a significant impact on whether one’s cancer is diagnosed, treated and cared for, in an appropriate and cost-effective manner. A customer-focused understanding of the dynamics of the cancer therapy segment, although may help effective ground action, but the status quo continues for various critical reasons. Even on the World Cancer Day 2019, the oncology pricing debate continued.

Conclusion:

The business dynamics for the cancer therapy segment, continues to remain enigmatic regardless of public emotion and sentiments attached to these drugs. Patients access and affordability to the most effective drug at the right time can save or take lives. Surprisingly, despite healthy growth of anti-cancer drugs, especially the newer and pricey ones, the number of deaths due to cancer is also fast increasing, and is the second largest cause of death today.

The pricing conundrum of cancer drugs remains the subject of a raging debate, globally. Nevertheless, the drug industry keeps justifying the mind-boggling prices, with the same sets of contentious reasons, even when various investigative research studies negate those claims. Moreover, when general public expects the drug industry to innovate both in the new drug discovery and also on making the drug prices affordable to a large section of the population, the industry doesn’t exhibit any interest to talk about the latter. Instead, they talk about PAP initiatives for improving access to such drugs. Notwithstanding independent research studies concluding that PAPs lack transparency, and is not an alternative for all those who want to fight the disease, in the most effective way.

The arguments and counterarguments continue. More effective cancer drugs keep coming with lesser number of cancer patients having access to those medicines, as patents prevail over the patients. The reverberation of the power of Big Pharma to stay in the chosen course – come what may, can also be felt from the reported statement of politically the most powerful person in the world – the President of the United States. In view of this, both the business and market dynamics of the cancer therapy segment is likely to remain enigmatic – at least, in the foreseeable future?

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.

 

Heath Care: My Expectations From The Union Budget (2016-17)

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India Celebrated its ‘Constitution Day’ on November 26 this year, as the Constitution of the country was adopted by the Constituent Assembly on November 26, 1949, which came into force on January 26,1950. 

On November 27, 2015, while addressing the Lok Sabha, Prime Minister Narendra Modi said, “If Constitution simply becomes a document to be followed by the Government then democracy will suffer, that’s why it needs to reach the roots.”

The Prime Minister also said, “It is important to strengthen rights and it is as important to strengthen duties.”

Looking at this laudable vision of Prime Minister Modi from the health care perspective, one finds that Indian Constitution also guarantees the ‘Right to Life’ to every Indian citizen.

This prompts two important questions:

- Has this specific ‘Constitutional Right’ – ‘‘Right to Life’, been upheld by any Government of our country, as on date, in its letter and spirit?

- Has this specific Constitutional Guarantee ‘reached the roots,” as the Prime Minister expects? 

A search for answers to these questions gets even more complicated, when one finds that health care, which is so fundamental for human ‘life’, besides driving the economic prosperity of any nation, is getting continuously neglected, even when the Prime Minister is reaching out to all, in pursuit of economic prosperity for the nation.

Better late than never:

As the Indian Parliament has taken a fresh vow in the current Winter Session to follow all the Constitutional provisions unhindered, I sincerely hope that the Union Budget 2016-17 would reflect some road map to uphold this important Constitutional Guarantee provided to all the citizens of India. 

If it truly happens, everybody would applaud the Government, in the right spirit of the good old dictum – it is ‘better late than never’.

What has the ‘Right to Life’ got to do with the Union Budget?

Yes, it is indeed a valid question, as what I am saying is a policy matter and is intimately related to ‘The National Health Policy of India”. 

As we know, a new draft of the ‘National Health Policy’ was prepared by the incumbent Government in 2015 for public discourse. However, the same has not been adopted, just yet.

Nevertheless, that’s not the reason why I am raising this issue in my pre-budget (2016-17) expectations. My argument is, any policy has to be supported by adequate financial commitment and that gets reflected in the Union Budget.

Repetition of the Union Finance Minister’s assertion on health care funding even for the next financial year, just what he did while presenting the Union Budget 2015-16, would no longer suffice, especially after the PM’s ‘Constitution Day’ speech.

Last year the FM had said that health care being a state subject, respective State Governments would make required financial allocations to address health related issues of the states.

Trying to substantiate his point the minister said, following the recommendations of the 14th Finance Commission, the Government has raised the States’ share in the net proceeds of union tax revenues from 32 per cent to 42 per cent.

In my view, not much progress in healthcare, pan India, can be expected with this approach of the Union Government. To implement the same robust ‘National Health Policy’ across the country effectively, the Central Government would require to work with the State Governments shoulder to shoulder in this regard and support them with all necessary resources.

Three fundamental pre-requirements:

I reckon, there are three fundamental pre-requirements to translate this specific Constitutional Guarantee into reality:

  • A robust “National Health Policy” should be put in place well before the Union Budget 2016-17, clearly charting a road map for health care in India. Going by the Prime Minister’s reported obsession on the speed of any decision making by his ministers, I hope, the ‘Health Policy’ rollout would commence soon. 
  • Prioritizing from this policy, the Central and the State Governments together should identify specific health projects, based on majority of citizen’s immediate health needs, for joint implementation. 
  • Allocate appropriate financial resources in both the Union and State Budgets for their speedy implementation, fixing accountability and commensurate reward to bring all these initiatives to fruition, ahead of schedule. 

My expectations on health care from the budget:

With the above backdrop, my overall expectations on health care allocations in 2016-17 Union Budget proposals are as follows:

  • Increase total public health expenditure from the current 1.2 percent to at least 2.0 percent of the GDP and then raise it 2.5 percent over a period of next three years.
  • The main source of financing for public health should remain general taxation by levying ‘Health Cess’, quite in line with with ‘Swachh Bharat Cess’ at the rate of 0.5 percent on all taxable services, besides adding a similar tax on non-essential and luxury items.

The key resource allocation would, at least, be in the following five key areas:

A. Infrastructure and capacity building:

- Focused and well-identified investments in building high quality public health infrastructure and well-skilled human resources for rural India on priority.

- Villages, based on population, would be identified by the respective State Governments.

B. Increasing access to quality public health care:

- Free universal access to primary care services to start with, across the country,

- Free drugs, free diagnostics and free emergency care services in all public hospitals of the country and for all. 

- Free emergency response and patient-transport systems across the country, for all.

C. Strengthening the supply chain:

- Quality drug and diagnostics procurement system by the Central Medical Services Society (CMSS) of the Government needs to be modernized, strengthened and made more efficient with real time data, for easy availability of all required drugs and diagnostics in all public hospitals at the right time and in the right quantity.

-  Today, many life saving drugs and diagnostics are highly temperature sensitive. Thus, adequate cold chain facilities are to be created right from transportation to storage in public hospitals for all such products, maintaining their required efficacy and safety standards for patients.

D. Increasing awareness for disease prevention:

- Intensive multi-pronged, multi-channel and door to door campaigns by the para-medics to increase awareness for identified disease prevention.

E. Performance incentive: 

- To achieve the desired level of success and increase the motivation level in a sustainable way, budgetary provisions to be made for a system of well-structured individual and team performance incentive scheme, when the key implementers exceed expectations by achieving the set goals well before schedule.

- Commensurate punitive measures for failure also to be put in place, simultaneously.

I would not broach upon the area of Research and Development (R&D) for drugs and diagnostics here, as that could probably be considered in a holistic way under overall innovation, science and technology budget allocation required for the country, as a whole.

Conclusions:

I sincerely hope and am also reasonably confident that all these would feature in the final version of the new “National Health Policy” of India. Hence, I have not suggested anything radically different from what the Government is currently mulling.

Thus, when my pre-budget (2016-17) expectations on health care, are read in conjunction with exactly what the PM has recently vowed on following the Constitution of India, and the criticality of taking it to the national grassroots level, it appears obligatory for the Finance Minister to ‘walk the line’, as drawn by the PM himself.

The Constitution of India guarantees ‘right to life’ for all, even in sickness.                                                                

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.

 

“Make in India…Sell Anywhere in The World”: An Indian Pharma Perspective

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In his Independent Day speech from the ramparts of the Red Fort on August 15, 2014, Indian Prime Minister Modi gave a clarion call to all investors of the world, “Come, make in India”, “Come, manufacture in India”, “Sell in any country of the world, but manufacture here”.

The Prime Minister did not stop there. In his inimitable style, following it through on September 25, 2014 he gave an official status to ‘Make in India’ slogan and launched a global campaign.

“My definition of FDI for the people of India is First Develop India. This is also a responsibility for the people of India,” he further clarified.

An Indian perspective:

If I juxtapose this vision of the Prime Minister in the Indian pharmaceutical industry perspective, one finds that many small, medium and large size local domestic manufacturers are currently manufacturing drugs not just for the domestic market, but are also exporting in large quantities to various countries of the world, including, North America, South America and Europe.

The United States (US) is one of the most critical markets for majority of the Indian drug exporters. This transaction was taking place without any major regulatory hitches since quite some time. Unfortunately, over the last few years, mostly the Federal Drug Administration of the US (USFDA) and the United Kingdom (UK)’s Medicines and Healthcare Products Regulatory Agency (MHRA) have started raising serious doubts on the quality of medicines manufactured in India, making a significant impact on the drug exports of the country.

Most of these quality issues are related to ‘Data Integrity’ in the dug manufacturing and its documentation processes.

The impact:

According to industry data, in 2013-14, Indian drug exports registered the slowest growth in nearly the last 15 years. In this fiscal year, pharma exports of the country with a turnover of US$ 14.84 billion grew at a meager 1.2 percent. Pharmexcil attributed its reason to USFDA related regulatory issues and increasing global competition.

US accounts for about 25 percent of India’s pharma exports and its Federal Drug Administration (USFDA) has been expressing, since quite a while, serious concerns on ‘Data Integrity’ at the agency’s  previously approved production facilities of a large number of Indian pharma players.

The issue is causing not just a serious concern to USFDA and some other overseas drug regulatory agencies, but also posing a huge threat to future growth potential of Indian drug exports.

It is worth noting that Indian government had set an objective, in its strategy document, to register a turnover of US$ 25 billion for pharma exports in 2014-15. In all probability, it would fall far short of this target at the end of this fiscal, predominantly for related reasons.

Why is so much of ‘fuss’ on ‘Data Integrity’?

Broadly speaking, ‘Data Integrity’ in pharmaceutical manufacturing ensures that finished products meet pre-established specifications, such as, for purity, potency, stability and sterility. If data integrity is breached in any manner or in absence of credible data, the product becomes of dubious quality in the eyes of drug regulators.

Manufacturing related ‘Data Integrity’ is usually breached, when data from a database is deliberately or otherwise modified or destroyed or even cooked.

Over the last several years, ‘Data Integrity’ related issues in India are attracting enormous attention of both the USFDA and the MHRA, UK. As a result, concerned pharma manufacturing facilities are receiving Import Alerts/Warning Letters from the respective overseas drug regulators, refusing entry of those medicines mostly in the United States and some in the UK.

Recent warning letters:

Just over a year – from May 2013 to July 2014, around a dozen ‘Warning Letters’ have been sent to the Indian drug manufacturers by the USFDA on ‘Data Integrity’ related issue, as follows:

Recent ‘Warning Letter’ issued to: Date of issue
1. Marck Biosciences Ltd. 08. 07. 2014
2. Apotex Pharmachem India Pvt Ltd. 17. 06. 2014
3. Sun Pharmaceutical Industries 07. 05. 2014
4. Canton Laboratories Private Limited 27. 02. 2014
5. USV Limited 06. 02. 2014
6. Wockhardt Limited 25. 11. 2013
7. Agila Specialties Private Limited 09. 09. 2013
8. Posh Chemicals Private Limited 02. 08. 2013
9. Aarti Drugs Limited 30. 07. 2013
10. Wockhardt Limited 18. 07. 2013
11. Fresenius Kabi Oncology Ltd 01. 07. 2013
12. RPG Life Sciences Limited 28. 05. 2013

(Source: RAPS, 19 August 2014)

Another report states that USFDA has, so far, banned at least 36 manufacturing plants in India from selling products in the US.

Importance of US for Indian generic players:

Generic drugs currently contribute over 80 percent of prescriptions written in the US. Around 40 percent of prescriptions and Over The Counter (OTC) drugs that are sold there, come from India. Almost all of these are cheaper generic versions of patent expired drugs. Hence, India’s commercial stake in this area is indeed mind-boggling.

The ‘Data Integrity’ issue is not restricted to just US or UK:

A report quoting researchers led by Roger Bate, an American Enterprise Institute scholar and funded by the The Legatum Institute and the Humanities Research Council of Canada, concluded that many Indian pharma companies follow double manufacturing standards, as they are sending poor quality drugs to Africa compared to the same pills sold in other countries. This study was based on tests of 1,470 samples produced by 17 Indian drug manufacturers.

Besides India, the researchers took drug samples from pharmacies in Africa and middle-income countries, including China, Russia and Brazil.

According to this paper, the researchers found that 17.5 percent of samples of the tuberculosis therapy rifampicin sold in Africa tested substandard, which means the drug has less than 80 percent of the active ingredient than what it should otherwise. Against this number, in India, 7.8 percent of the medicine sampled was found substandard.

Moreover, Almost 9 percent of samples of the widely used antibiotic ciprofloxacin sold in Africa tested substandard, as compared to 3.3 percent in India.

Thorny issues around golden opportunities:

Much reported breach in manufacturing ‘Data Integrity’ detected at the manufacturing sites in India, are throwing fresh doubts on the efficacy and safety profile of generic/branded generic medicines, in general, produced in the country and more importantly, whether they are putting the patients’ health at risk.

A new analysis by the U.S. National Bureau of Economic Research pointed out some thorny issues related to ‘Data Integrity’ of drugs produced by the Indian pharmaceutical companies, which supply around 40 percent of the generic drugs sold in the United States, as stated above.

The researchers examined nearly 1,500 India-made drug samples, collected from 22 cities and found that “up to 10 percent of some medications contained insufficient levels of the key active ingredients or concentrations so low, in fact, that they would not be effective against the diseases they’re designed to treat.”

The report also highlighted that international regulators detected more than 1,600 errors in 15 drug applications submitted by Ranbaxy. The Bureau Officials commented that these pills were “potentially unsafe and illegal to sell.”

Frequent drug recalls by Indian pharma majors:

The above findings came in tandem with a series of drug recalls made recently by the Indian pharma companies in the US.

Some of the reported recent drug recalls in America, arising out of manufacturing related issues at the facilities of two well-known Indian pharma majors, which are going to merge soon, are as follows:

  • Sun Pharmaceuticals recalled nearly 400,000 bottles of the decongestant cetirizine (Zyrtec) and 251,882 of the antidepressant venlafaxine (Effexor) this May, because the pills failed to dissolve properly. The drugs were distributed by the drug maker’s US subsidiary Caraco Pharmaceutical Laboratories, but were manufactured in India.
  • In the same month – May, Ranbaxy recalled 30,000 packs of the allergy drugs loratadine and pseudo-ephedrine sulphate extended release tablets because of manufacturing defects in packaging.
  • In March, Sun Pharma recalled a batch of a generic diabetes drug bound for the US after an epilepsy drug was found in it. A patient discovered the error after noticing the wrong medication in the drug bottle.
  • Again in March, Ranbaxy recalled nearly 65,000 bottles of the statin drug atorvastatin calcium (Lipitor) after 20-milligram tablets were found in sealed bottles marked 10-milligrams. A pharmacist in the U.S. discovered the mix up.

Indian media reinforces the point:

Indian media (TNN) also reported that there is no quality control even for life-saving generic drugs and the government is apathetic on ensuring that the quality protocol of these drugs is properly observed.

This happens, as the report states, despite government’s efforts to push generic drugs, as they are more affordable. The report gave an example of a life-saving drug, Liposomal Amphotericin B, which is used to treat fungal infections in critically ill patients.

Are all these drugs safe enough for Indian Patients?

Though sounds awkward, it is a fact that India is a country where ‘export quality’ attracts a premium. Unintentionally though, with this attitude, we indirectly accept that Indian product quality for domestic consumption is not as good.

Unfortunately, in the recent years, increasing number of even ‘export quality’ drug manufacturing units in India are being seriously questioned, warned and banned by the overseas drug regulators, such as USFDA and MHRA, UK, just to ensure dug safety for the patients in their respective countries.

Taking all these into consideration, and noting increasing instances of blatant violations of cGMP standards and ‘Data Integrity’ requirements for ‘export quality’ drugs, one perhaps would shudder to think, what could possibly be the level of conformance to cGMP for the drugs manufactured solely for the consumption of local patients in India.

A cause of concern, as generic drugs are more cost effective to patients:

It has been widely recognized globally that the use of generic drugs significantly reduces out-of-pocket expenditure of the patients and also payers’ spending.

The findings of a study conducted by the Researchers from Brigham and Women’s Hospital (BWH), Harvard Medical School and CVS Health has just been published in the Annals of Internal Medicine on September 15, 2014. In this study the researchers investigated whether the use of generic versus brand name statins can play a role in medication adherence and whether or not this leads to improved health outcomes. The study concluded that patients taking generic statins were more likely to adhere to their medication and also had a significantly lower rate of cardiovascular events and death.

In this study, the mean co-payment for the generic statin was US$10, as against US$48 for brand-name statins. It is generally expected that the generic drugs would be of high quality, besides being affordable.

I deliberated on a related subject in one of my earlier blog posts of November 11, 2013 titled, “USFDA” Import Bans’: The Malady Calls For Strong Bitter Pills”.

Conclusion:

According to USFDA data, from 2013 onwards, about 20 drug manufacturing facilities across India attracted ‘Import Alerts’ as against seven from China, two each from Australian, Canadian and Japanese units and one each from South African and German facilities.

Unfortunately, despite intense local and global furore on this subject, Indian drug regulators at the Central Drugs Standard Control Organization (CDSCO), very strangely, do not seem to be much concerned on the ‘Data Integrity’ issue, at least, not just yet.

In my view, ‘Data Integrity’ issues are mostly not related to any technical or other knowledge deficiency. From the “Warning Letters” of the USFDA to respective Indian companies, it appears that these breaches are predominantly caused by falsification or doctoring of critical data. Thus, it basically boils down to a mindset issue, which possibly pans across the Indian pharma industry, irrespective of size of operations of a company.

Indian Prime Minister’s passionate appeal aimed at all investors, including from India, to “Make in India” and “Sell Anywhere in The World”, extends to pharma industry too, both local and global. The drug makers also seem to be aware of it, but the ghost keeps haunting unabated, signaling that the core mindset has remained unchanged despite periodic lip service and public utterances for corrective measures by a number of head honchos.

Any attempt to trivialize this situation, I reckon, could meet with grave consequences, jeopardizing the thriving pharma exports business of India, and in that process would betray the Prime Ministers grand vision for the country that he epitomized with, “Make in India” and “Sell Anywhere in The World”.

By: Tapan J. Ray

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

My thoughts on the world IPR day, April 24

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Ushering in the Product Patent Regime in India, effective January 1, 2005, heralds the dawn of a new era… an era that is expected to add speed to the wheels of progress of the nation. The new paradigm vindicates the importance of encouraging, protecting and rewarding innovation to meet the unmet needs of the population. At the same time this change instills new hope in our mind that India will now compete with the bests in the world, more innovatively and effectively, to curve out a significant share of the global economy.

Criticism continues, unfortunately though…

However, it is quite unfortunate that the pharmaceutical product patents that protect today’s innovations and drive research and development to create tomorrow’s life-saving treatments, are under criticism from some quarters. India chose to follow an alternative to Product Patent regime for many years. In 1970, the Government of India amended its IP laws with a clear objective in mind to reduce the prices of medicines to improve their access to the ailing population of the country.

A panacea:

As a result, some drugs were made cheaper. However, the moot question that we need to address now: was it a panacea? While looking back, it does not really appear so. On the contrary, the situation remained as gloomy thereafter, so far as the access to medicines is concerned. After almost four decades of continuation with the above policy, around 65% of Indian population still does not have access to cheaper off-patent medicines against comparative figures of 47% in Africa and 15% in China.

Children still go without routine vaccinations, though the Government has made the primary vaccination programs free in our country, for all. Even in a situation like this, where affordability is no issue, only about 44% of infants (12 – 23 months) are fully vaccinated against six major childhood diseases – tuberculosis, diphtheria, pertussis, tetanus, polio and measles. Moreover, as we know, despite distribution of cheaper generic HIV AIDS drugs by the Government and others mostly free for years, only 5% cent of India’s AIDS patients were receiving any drugs by the end of 2006.

The above two important examples prove the point very clearly that addressing the issue of price alone will not help our country to solve the issue of poor access to medicines to the ailing population of India. Only a sharp focus on rejuvenation of our fragile healthcare delivery system, healthcare financing and rapid development of healthcare infrastructure of the country by the Government or through Public Private Partnership (PPP), will help address this pressing issue.

 

Paving way for innovation…issues of affordability and access need to be addressed differently :

Indian Patents Act 2005 has paved the way for innovation and hi-tech research and development within the country. Contrary to adverse forecasts from some quarters, prices of medicines have not gone up.

However, while medicines play a relatively small role in rising overall healthcare spending including hospitalization, it is important to ensure that individuals with large healthcare expenses have affordable access to required medicines. Thus a good affordable insurance coverage (both Government and Private) available to all Indians belonging to various socio-economic strata, together with the above measures, will help address the key issues of both access and affordability of medicines to all, in a holistic way.

IPR regime…is it more robust in China?

India is continuously compared with China in various parameters both within and outside the country. It is known to all that China is now attracting more Foreign Direct Investments (FDIs), be it Pharmaceutical R&D or Clinical developments of the new drugs. The moot question is why?

India restricts incremental innovation with section 3(d) of the Patents Act, but China has no such restrictive provisions. India does not protect regulatory data of the innovators, but China does. India does not have any patent linkage system with the marketing approval of the generic versions of the patented molecules, but China has put in place such system in their country.

With all these has India been able to improve affordability and access to medicines better than China or as even much as China? No, unfortunately, it has not. In China about 85% of the population has access to medicines, in India the equivalent figure will read as just 35%. Why then are such restrictions in the Patents Act of India? Have the drug prices gone up disproportionately in India post 2005? No… Not really. Unfortunately, the share of voice of the generic industry on these issues being much shriller, the voice of the innovator companies, be it Indian or global, is getting lost in the din, on all these important issues.

Conclusion:

The attack on patents is not a defense of patients or the poor. Such attacks help diverting attention from the core healthcare issues, as mentioned above. Health of our nation will depend on how well these key issues are being addressed by the policy and decision makers. Our country cannot afford to ignore the fact that intellectual property is one of the keys to prosperity of a great nation like India and it should be encouraged, protected and rewarded under a robust patents act of the country for inclusive growth.

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.