Tag Archives: Draft

Drug Prescription In Generic Names Only, No Branded Generics

Posted on by
Reply

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

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

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

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

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

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

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

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

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

The final notification goes beyond drug prescription in generic names:

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

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

The Indian Medical Association (IMA) Protested against it:

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

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

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

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

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

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

Here are some of the most common reasons:

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

Some ways to encourage doctors to prescribe generic drugs:

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

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

Conclusion:

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

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

By: Tapan J. Ray      

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

 

Self-made Barriers To Business Transparency Impacting Drug Access

Posted on by
Reply

A recently published book on pharma industry tried to expose the deceit behind many generic-drug manufacturing—and the consequent risks to global health. This publication is described as an ‘explosive narrative investigation of the generic drug boom that reveals fraud and life-threatening dangers on a global scale.’ However, I reckon, this is just a part of the story, and its huge adverse impact on public health flows generally from the following facts:

  • Greater use of generic drugs is hailed as one of the most important public-health developments of the twenty-first century.
  • Today, almost 90 percent of global pharma market, in volume terms, is comprised of generics.
  • These are mostly manufactured in China and India.
  • The drug regulators continuously assure patients and doctors that generic drugs are identical to their brand-name counterparts, just less expensive.

No question, such deceit, blatant fraud and data manipulation – seriously affecting drug quality of generic medicines, shake the very purpose of making affordable drugs accessible to many. But, simultaneously, lack of transparency – right across the various functions of a pharma business, is also making a host of modern life-saving drugs unaffordable and inaccessible to even more patients. Although, both are despicable acts, but the latter one is not discussed as much.

Thus, in this article, I shall dwell on the second one – how attempts for pharma business ‘transparency’ for expanded drug access to patients, getting repeatedly foiled, especially in light of what happened on May 28, 2019, in the 72nd World Health Assembly (WHA).

Does pharma want low business transparency to continue?

Despite so many encouraging initiatives being taken in the pharma industry over a period of time, gross lack of transparency in its business continues, since long, despite this is being a raging issue. The obvious question, therefore, remains: Does pharma want low business transparency to continue? Thus, to give a perspective to this pertinent point, I shall quote two important observations, appeared in ‘MIMS Today’ – the first one on April 17, 2017, and the other came a year before that, on November 20, 2016, as follows:

  • “A market cannot function when purchasers have limited information and, in the case of prescription drugs, pricing is a black box. Prices for drugs are clearly rising at rates that far exceed inflation and the level of any rebates or discounts offered by manufacturers,” experts opined. They further said, to hold the industry accountable, Access to Medicine Foundation (AMF)’ regularly compiles an index to rank the progress made by each large drug maker in the area of business transparency. Curiously, they concluded, ‘the number and quality of evaluations for the effectiveness of these programs are lacking.’
  • “Lack of transparency of drug makers was also identified. Their policy positions, political contributions, marketing activities and memberships in associations and the associated financial support provided and board seats held were all analyzed. And only then, the ‘AMF’ reached a consensus that transparency remains low in all areas. The analysts further added, ‘there is a lack of transparency and rigor in monitoring and evaluating the access-to-medicines initiatives as well as the link between prices and development costs. Thus, ‘greater transparency from manufacturers to disclose R&D costs for drugs and evaluation of the initiatives’ is imperative.

Despite key policy makers’ favoring transparency, it remains elusive:

To illustrate this point, let me draw a recent example from the United States.

Alex M. Azar II, who is currently the Secretary of Health and Human Services of the United States, also served as president of Eli Lilly USA. LLC from 2012 to 2017 supports the need of business transparency in the pharma industry. Last year, he also emphasized:

“Putting patients in charge of this information is a key priority. But if we’re talking about trying to drive not just better outcomes, but lower costs, we also have to do a better job of informing patients about those costs. That is where our emphasis on price transparency comes in.” By naming the key health care product and service providers, Azar added, “So this administration is calling on not just doctors and hospitals, but also drug companies and pharmacies, to become more transparent about pricing and outcomes of their services and products.”

Like Secretary Azar, policy makers in several other countries, including India, are also talking and seemingly in favor of transparency in health care business systems, but it remains elusive, as we shall see below.

Do vested interests create over-powering pressure to maintain status-quo?

The above examples give some idea about the pressure created by vested interested to maintain a status-quo in this important area. Although, business transparency is a must, pharma influence on policy makers is so powerful that even a recent global resolution on the subject, had to dilute its original version in its final avatar, significantly, which I shall now focus on, as yet another vindication on this issue.

The final version of the 2019 WHA resolution made weaker in transparency:

On May 28, 2019, by a News Release in Geneva, the World Health Organization (W.H.O) announced, to help expand access to medicines for all, the72nd World Health Assembly (WHA) adopted a significant resolution on improving the transparency of markets for medicines, vaccines and other health products, globally. I repeat, this was a global effort to expand access. The assembly brought together delegates from 194 Member States of the W.H.O, including India – from 20 to 28 May 2019, in Geneva, Switzerland.

Intriguingly, as several reports highlighted, ‘the final resolution is considerably weaker than the original draft.’ Nevertheless, it still provides, at least, some measures, which have potential to make an impact on market access, globally.

What exactly was the 2019 WHA original resolution?

The original WHA draft resolution, titled ‘Roadmap for access 2019-2023 – Comprehensive support for access to medicines and vaccines’, urged the Member states the following:

  • To enhance public sharing of information on actual prices paid by governments and other buyers for health products,
  • Greater transparency on pharmaceutical patents, clinical trial results and other determinants of pricing along the value chain from laboratory to patient.
  • Requests the WHO secretariat to support efforts towards transparency and monitor the impact of transparency on affordability and availability of health products, including the effect of differential pricing.

Highlighting that access to medicines is the key to advancing the Universal Health Coverage (UHC), the resolution aims to help the Member States:

  • To make more informed decisions when purchasing health products,
  • Negotiate more affordable prices
  • And ultimately expand access to health products for the populations.

Palpable discomfort of large pharma associations:

The May 30, 2019 article of the Pharm Exec Magazine on this resolution, carried a headline with a query: Is it ‘A Watershed on Transparency and International Collaboration in Drug Pricing?’ The paper brought out some important points that may help explain why the 2019 original WHA resolution, could not be adopted as such. Apparent discomfort in this regard of some top industry associations, which were created and fully funded by large global drug companies, was palpable, according to this report.

For example, “the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), warned governments ‘to carefully consider potential risks to patients, particularly in less developed countries, of sharing outcomes of confidential price negotiations across countries.’ The implication is that prices in less-affluent countries could rise if the wealthier nations used international transparency to demand lower prices for their markets.”

Why couldn’t the original resolution on business transparency be adopted?

To instantiate the level of discomfort of vested interests, let me highlight some critical changes made in the 2019 in final WHA resolution at the international level, as I get from the above paper. A few of which are as follows:

In the original draft Changes in the final resolution
1. “Undertake measures to publicly share information on prices and reimbursement cost of medicines, vaccines, cell and gene-based therapies and other health technologies.” Refers to publicly sharing of information only on net prices.
2. “Require the dissemination of results and costs from human subject clinical trials, regardless of outcome or whether the results will support an application for marketing approval.” “Take the necessary steps, as appropriate, to support dissemination of and enhanced availability of and access to aggregated results data and, if already publicly-available or voluntarily-provided, costs from human subject clinical trials regardless of outcomes or whether the results will support an application for marketing approval.”
3. “Require the publication of annual reports on sales revenue, prices, units sold, and marketing costs for individual products, as well as details of the costs of each trial used to support a marketing authorization application and information on financial support from public sources used in the development of a drug.” Calls on the member states to “work collaboratively to improve the reporting of information by suppliers on registered health products, such as reports on sales revenues, prices, units sold, marketing costs, and subsidies and incentives.”
4. Wanted the WHO Director-General to “propose a model/concept for the possible creation of a web-based tool for national governments to share information, where appropriate, on medicines prices, revenues, units sold, patent landscapes, R&D costs, the public sector investments and subsidies for R&D, marketing costs, and other related information, on a voluntary basis.” Diluted only to “assessing the feasibility and potential value of establishing a web-based tool to share information relevant to the transparency of markets for health products, including investments, incentives, and subsidies.”
5. Proposed the creation of a forum to “develop suitable options for alternative incentive frameworks to patent or regulatory monopolies for new medicines and vaccines” that would both promote universal health coverage and adequately reward innovation. This point doesn’t find any place in the final resolution.

It appears, the final 2019 WHA resolution has been able to remove the key points of discomfort for the drug industry – caused by greater business transparency. It is largely due to the fact that the final pledges ‘consist largely of recommendations for voluntary action rather than the requirements for comprehensive disclosure proposed in the original draft.’

Conclusion:

To arrive at a consensus, especially over promoting transparency in costs incurred towards R&D of drugs and health-related technologies, appeared challenging for the W.H.O Member States, inthe 72nd World Health Assemblythat concluded on May 28, 2019.Overall resolution changed the narrative from a mandatory process to a voluntary initiative. As I said before, it still prescribes several measures, which can help expand access to medicines for all, across the world.

In tandem, it also comes out clearly that barriers to business transparency to ensure better access to drugs for all, across the world, are not easy to uproot, either. Especially, when it comes to fighting against concerted efforts of powerful pharma lobby groups, other vested interests and some looney fringes.

The process of adoption of the May 2019 WHA final resolution of the world’s most relevant public health issues, is just an example.

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.

Marketing Practices: Why Pharma Does What It Does?

Posted on by
Reply

It started way back – spanning across many developed countries of the world. However, probably for the first time in the last five years, an international media group focused on this issue thriving in India, with so much detail.

Reuters reported it with a headline “In India, gift-giving drives drug makers’ marketing.” The report was supported by a detailed description of the relevant events, with ‘naming and shaming’. It drew the attention of some, apparently including the Department of Pharmaceuticals (DoP), but escaped the attention of many, and finally – got faded away with time, without any reported official investigation.

In this article, I shall revisit this subject against the backdrop of draft pharma policy 2017. My focus will be on the current marketing practices, with the moot question ‘why pharma does what it does’ occupying the center stage of this piece.

Bothering many across the world:

Pharma marketing practices wear different hues and shades. Many of these are contentious, and often perceived as gross ‘malpractices’. Nevertheless, across the world, these have mostly become an integral part of pharma business. Many law-enforcing authorities, including in the US, Europe, Japan and even China, have started taking tough penal action against those transgressions. Interestingly, the draft pharma policy 2017 intends to take this raging bull by its horn, with a multi-pronged approach, as I see it.

It’s a different debate, though, whether the policy makers should bring the mandatory Uniform Code of Pharmaceutical Marketing Practices (UCPMP) under the Essential Commodities Act, or the Drugs and Cosmetics Act of India. Let’s wait and see what exactly transpires in scripting the final version of the new National Pharma Policy to address this issue, comprehensively.

The net impact of the fast evolving ‘newer norms’ of pharma ‘marketing’ practices, has been bothering a large section of the society, including the Governments, for quite some time. Consequently, many top-quality research studies are now being carried out to ascertain the magnitude of this problem. The top ranked pharma market in the world – the United States (US) are leading the way with such analysis. However, I haven’t come across similar India-specific analytical reports, just yet, probably due to lack of enough credible data sources.

Four recent studies:

Several interesting studies supported by a robust database have been carried out in the US during 2016 and 2017 to ascertain whether any direct relationship exists between payments in various forms made to the doctors by the pharmaceutical companies and physicians’ prescribing various drugs in brand names. For better understanding of this issue, I am quoting below, as examples, the gist of just four of such studies:

One of these studies conducted by ProPublica was published in March 2016. It found that physicians in five common medical specialties who accepted, at least one industry payment were more likely to prescribe higher rates of brand-name drugs than physicians who did not receive any payments. More interestingly, the doctors receiving larger payments had a higher brand-name prescribing rate, on an average. Additionally, the type of payment also made a difference: those who received meals alone from companies had a higher rate of brand-name prescribing than physicians receiving no payments, and those who accepted speaking payments had a higher rate of the same than those drawing other types of payments.

The details of the second study published in PLOS on May 16, 2016 states, “While distribution and amount of payments differed widely across medical specialties, for each of the 12 specialties examined the receipt of payments was associated with greater prescribing costs per patient, and greater proportion of branded medication prescribing. We cannot infer a causal relationship, but interventions aimed at those physicians receiving the most payments may present an opportunity to address prescribing costs in the US.”

The third example of such investigative study appeared in the Journal of American Medical Association (JAMA) on August 2016. This cross-sectional analysis, which included 279,669 physicians found that “physicians who received a single meal promoting the drug of interest, with a mean value of less than $20, had significantly higher rates of prescribing rosuvastatin as compared with other statins; nebivolol as compared with other β-blockers; olmesartan as compared with other angiotensin-converting-enzyme inhibitors and angiotensin-receptor blockers; and desvenlafaxine as compared with other selective serotonin and serotonin-norepinephrine reuptake inhibitors.”

This study also concluded that “Receipt of industry-sponsored meals was associated with an increased rate of prescribing the brand-name medication that was being promoted. The findings represent an association, not a cause-and-effect relationship.”

And the fourth analysis on the same subject featuring in the British Medical Journal (BMJ) of 18 August 2016 concluded that “Payments by the manufacturers of pharmaceuticals to physicians were associated with greater regional prescribing of marketed drugs among Medicare Part D beneficiaries. Payments to specialists and payments for speaker and consulting fees were predominantly associated with greater regional prescribing of marketed drugs than payments to non-specialists or payments for food and beverages, gifts, or educational materials.”

Exceptional steps by a few global CEOs – would the rest follow through?

As this juggernaut continues to move unrelenting, a few global CEOs have been taking some exceptional steps in this regard, e.g.:

- In December 2013, Sir Andrew Witty –  erstwhile global CEO of  GlaxoSmithKline tossed out the ‘Big Pharma marketing playbook’. He announced, no longer will his company pay doctors to promote its drugs or shell out bonuses to sales reps based on their ability to boost prescription numbers.

- Around September 2015, Brent Saunders – the Global CEO of Allergan was the first major drug company chief to explicitly renounce egregious price increases. Outlining his company’s “social contract with patients,” he vowed that Allergan would:

  • Limit price increases to single-digit percentages, “slightly above the current annual rate of inflation,” net of rebates and discounts
  • Limit price increases to once per year
  • Forego price increases in the run-up to patent expiration, except in the case of corresponding cost increases.

- In October 2016, Joseph Jimenez – the current global CEO of Novartis said, “We tell people, we don’t want you to deliver at any cost. We want you to deliver, but we want you to deliver in the right way,”

It’s probably a different matter, though, that one of these CEOs has already stepped down, another will do so early 2018, and third iconoclast is still in the saddle. They all are still relatively young, as compared to several of their counterparts.

These are some of the laudable steps taken by a few CEOs for their respective global operations. However, the moot question remains: would rest of the Big Pharma constituents come on board, and successfully follow these initiatives through?

That said, the overall scenario in this area, both in India and abroad, continues to remain mostly unchanged.

Why pharma does what is does?

This may not be akin to a million-dollar question, as its right answer is no-brainer – to generate more, and even more prescription demand for the respective focused brands of the concerned pharma companies. In a scenario, as we have seen above, when money can buy prescriptions with relative ease, and more money buys more prescriptions, how do the prescribers differentiate between different brands of the same molecules or combination of molecules, for greater support?

As evident from various available reports, this kind of intangible product differentiation of dubious nature, doesn’t necessarily have a linear relationship with the quantum of money spent for this purpose. Many believe, it is also intimately related to the nature or kind of various ‘gratis’ extended, some of which are highly contentious. Illustratively, how exotic is the venue of so called ‘Continuing Medical Education (CME)’ event, whether located in India or beyond its shores, bundled with the quality of comfort provided by the event managers, or even whether the spouses can also join the doctors for a few days of a relaxed trip with fabulous sight-seeing arrangements.

Regardless of many pharma players’ terming these events as purely educational in nature, lots of questions in this regard – accompanied by proof, have reportedly been raised on the floor of the Indian Parliament, as well, cutting across virtually all political party lines.

Conclusion:

Should anyone tag the term ‘marketing’ against any such pharma business practices, or even remotely accept these as integral parts of any ‘branding exercise’? For better understanding of my readers, I had explained what this buzzword – ‘branding’ really means in the marketing vocabulary.

Be that as it may, where from the pharma companies recover the huge cost of such vexed business practices? Who ultimately pays for these – and, of course, why? So far, in India, the basic reasoning for the same used to be – branded generics provide significantly better and more predictable drug quality and efficacy than non-branded generics, for patients’ safety.

This logic is anchored mainly on the argument that bioequivalence (BE) and bioavailability (BA) studies are mandatory for all generic drug approvals in India. Interestingly, that loose knot has been tightened in the draft pharma policy proposals 2017. Hope, this commendable policy intent will ultimately see the light of the day, unless another innovative new reason pops-up.

Against this backdrop, many ponder: Are the current pharma ‘marketing’ practices, especially in India, akin to riding a tiger? If the answer is affirmative, the aftermath of the new pharma policy’s coming into force – broadly in its current form and with strict enforcement measures, could well be too tough to handle for those drug players without a Plan B ready.

That said, pharma ‘marketing’ ballgame is getting increasingly more complex, with the involvement of several third-parties, as is often reported. Alongside, it’s equally challenging to fathom ‘why pharma does what it does’ to generate more prescription demand at an incremental cost, which far exceeds commensurate incremental value that branded generics provide to patients in India.

By: Tapan J. Ray 

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

Draft Pharma Policy 2017 Ticks The Right Boxes: A Challenge Still Remains

Posted on by
Reply

Pharma policy is not a panacea to address all related issues, neither for the patients nor the industry, in general. As I see it, it’s no more than a critical cog in the wheel of the overall macro and the micro health care environment in India. Regardless of this fact, and notwithstanding virtually inept handling of previous pharma policies in many critical areas, each time a new policy surfaces, it generates enough heat for discussion.

Interestingly, that happens even without taking stock in detail of the success or failure of the previous one. A similar raging debate maintaining the same old tradition, has begun yet again with the Draft Pharma Policy 2017. This debate predominantly revolves around the direct or indirect interests of the industry, and its host of other associates of various hues and scale.

Having said that, the broad outline of the 18-page draft policy 2017 appears bolder than previous ones in several areas, and has ticked mostly the right boxes, deserving immediate attention of the Government. One such aspect I discussed in my previous article, titled “Draft Pharma Policy 2017 And Branded Generics,” published in this blog on August 28, 2017.

There are obviously some loose knots in this draft policy, a few are contentious too, such as the changing role of National Pharmaceutical Pricing Authority (NPPA), which apparently is doing a reasonably good job. I also find its link with several important national initiatives, especially ‘Make in India’, ‘Digital India’ and ‘Skill development’. Above all, the draft policy reflects an unambiguous intent to stop several widely-alleged business malpractices – deeply ingrained in various common, but important industry processes and practices that include, pharma sales and marketing, serious quality concern with many loan licensing manufacturers, and even in the issues related to ‘Product to Product (P2P) manufacturing.

The Department of Pharmaceuticals (DoP) reportedly commenced the preliminary rounds of discussion on August 30, 2017, where the Ministry of Health, the Ministry of Environment and the Department of Commerce also participated in the deliberation. In this article, I shall not go into the speculative areas of what ought to or ought not to come finally, instead focus on the key challenges in making the pharma policy meaningful, especially for the patients, besides the industry.

Policy implementation capability:

Whatever may be the net outcome of these discussions, and the final contours of the National Pharma Policy 2017, the implementation capability of the DoP calls for a thorough overhaul, being the primary challenge in its effective implementation. Since 2008, several illustrious bureaucrats have been at the helm of this important department, but nothing substantial seems to have changed in the comprehensive implementation of pharma policies, just yet. Concerned stakeholders continue to wait for a robust patented drug pricing policy, or for that matter even making the Uniform Code of Pharmaceutical Marketing Practices (UCPMP) mandatory, which, going by what the DoP officials had reportedly hinted at many times, should have been in place by now.

The core reason for the same could well be due to a structural flaw in the constitution of DoP under the Ministry of Chemicals and Fertilizers, instead of making it a part of the Ministry of Health. The reason being to create a greater synergy in the implementation of both the Pharma and Health Policies, in a more meaningful way. But, that could be a topic of a separate discussion, altogether.

Initial adverse impact on the pharma industry:

Some of the following proposals, as articulated in the draft pharma policy 2017, are likely to cause initial adverse impact on the performance of the industry, especially considering the way the industry, in general, has been operating over a long time:

  • No brand names for single molecule drugs
  • Mandatory UCPMP with heavy penal provisions
  • e-prescriptions facilitating greater usage of less expensive high quality drugs with only generic names
  • Mandatory BE/BA studies for all generic drug approvals
  • GMP and GLP requirements in all manufacturing facilities
  • Restrictions on loan-licensing and P2P manufacturing.

Initial retarding impact, out of the above measures, may be felt on pharma revenue and profit growth, increase in overall manufacturing cost, and more importantly on the long term strategic game plans of most pharma players, in one way or the other.

The Government is aware of it:

Nevertheless, to make a significant course correction through policy interventions, in curbing widely reported alleged marketing and other malpractices, dubious quality standards of many drugs, and sufferings of many patients with high out of pocket drug expenditure, the Government apparently firmly believes that such an outcome is unavoidable, although need to be minimized. The following paragraph detailed in the Annual Report 2016-17 of the Department of Pharmaceuticals, vindicates the point:

“The domestic Pharma market witnessed a slowdown in the ongoing financial year owing to the Government’s efforts to make medicines affordable. The impact of this can be seen in the industry’s financials as well. The drugs & pharmaceuticals industry reported poor sales performance for two consecutive quarters ended September 2016. Sales grew by a mere 2.9 per cent in the September 2016 quarter, after a sluggish 2.5 per cent growth registered in the June 2016 quarter. The industry’s operating expenses rose by 5.4 per cent during the September 2016 quarter, much faster than the growth in sales. As a result, the industry’s operating profit declined by 5.4 per cent. Operating margin contracted by 185 basis points to 21.1 per cent. A 3.4 per cent decline in the industry’s post-operating expenses restricted the decline in its net profit to 0.8 percent. The industry’s net profit margin contracted by 160 basis points to 13.7 per cent during the quarter.”

Just the pharma policy won’t increase access to health care or drugs:  

Just a pharma policy, irrespective of its robustness, is unlikely to increase access to health care or even medicines, significantly, despite one of the key objectives of the draft pharma policy 2017 being: “Making essential drugs accessible at affordable prices to the common masses.” This articulation is nothing new, either. It has been there in all pharma policies, since the last four decades, but has not been able to give the desired relief to patients, till date.

Pharma and Health Policies need to work in tandem:

To be successful in this direction, both the Pharma and the Health Policies should be made to work in unison – for a synergistic outcome. This is like an individual musician creating his or her own soothing music, following the exact notations as scripted by the conductor of a grand symphony orchestra. The orchestrated music, thus created is something that is much more than what a solo musical player will be able to create.

This is exactly what is not happening in the health care ecosystem of India, over decades, and continues even today. Each of the Pharma and Health policies are implemented, if at all, separately, apparently in isolation to each other, while the holistic picture of health care remains scary, still progressing at a snail’s speed in the country!

The predicament of the same gets well reflected in a World Bank article that states:

“In India, where most people have dug deep into their pockets to pay doctors, pharmacies and diagnostic centers (or ‘out-of-pocket spending’) as the norm for a long time, vulnerability to impoverishment caused by medical expenses remains high. Though government health spending is estimated to have steadily risen to 30% of the country’s total health expenditure – up from about 20% in 2005 – and out-of-pocket payments have fallen to about 58%, dropping from 69% a decade ago, these levels are still high and not commensurate with India’s level of socioeconomic development. In fact, the average for public spending on health in other lower middle-income countries is more than 38%, while in China, government spending accounts for 56% of total health expenditure.”

Affordable drug – just one parameter to improve its access :

While ‘making essential drugs accessible at affordable prices to the common masses’ is one of the top objectives of the draft pharma policy. The degree of its success is intimately linked with what the National Health Policy 2017 wants to achieve. It promises ‘improved access and affordability, of quality secondary and tertiary care services through a combination of public hospitals and well measured strategic purchasing of services in health care deficit areas, from private care providers, especially the not-for profit providers.’

The Health Policy 2017 also states: ‘Achieving a significant reduction in out of pocket expenditure due to health care costs and achieving reduction in proportion of households experiencing catastrophic health expenditures and consequent impoverishment.’ It is no-brainer to make out that reducing out of expenses on drugs is just one element of reducing overall out of pocket expenditure on overall health care. When there is no, or very poor access to health care for many people in India, improving access to affordable drugs may mean little to them.

A major reason of the ongoing ‘Gorakhpur Hospital’ tragedy, is not related to access to affordable drugs, but access to affordable and a functioning public health care system nearby. In the absence of any adjacent and functioning Government health facilities, the villagers had to commute even 150 to 200 kilometers, carrying their sick children in critical conditions to Gorakhpur. The question of access to affordable drugs could have arisen, at least, for them, if the country would not have lost those innocent children due to gross negligence of all those who are responsible for such frequent tragedies.

Thus, improving access to affordable essential drugs, as enunciated in the pharma policy, depends largely on improving access to affordable and quality public health care services. Both are intertwined, and require to be implemented in unison. Without the availability of affordable health care services, the question of affordable essential drugs would possibly be akin to putting the cart before the horse.

Conclusion:

The degree of resistance, presumably from the industry and its associates, to have a new and robust National Pharma Policy that meets the related needs and aspirations of the nation, in an inclusive manner, is generally much more than any National Health Policy, for obvious reasons.

As several proposed changes in the draft pharma policy 2017 appear radical in nature, its grand finale, I reckon, will be more interesting. At the same time, navigating through the waves of tough resistance, coming both from within and outside, will possibly not be a piece of cake, either, for the policy makers achieve the stated goals. Nevertheless, in that process, one will get to watch where the final decision makers give-in or dilute the proposals, and where they hold the ground, supported by a solid rationale for each.

Thus, the bottom line is: Where exactly does the challenge lie? In my view, both the National Health Policy 2017, and the Draft Pharma Policy 2017 mostly tick all the right boxes, especially in ‘making essential drugs accessible at affordable prices to the common masses’.

However, the fundamental challenge that still lies ahead, is to effectively translate this noble intent into reality. It would call for making both these policies work in tandem, creating a synergy in pursuit of meeting the nation’s health and socioeconomic needs on access to affordable health care for all, including medicines.

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.

 

Draft Pharma Policy 2017 And Branded Generics

Posted on by
Reply

In its first reading, the 18-page draft Pharma Policy, 2017 gives me a sense that the Government has followed the much-desired principle of ‘walk the talk’, especially in some key areas. One such space is what Prime Minister Modi distinctly hinted on April 17, 2017, during the inauguration function of a charitable hospital in Surat. He clearly signaled that prescriptions in generic names be made a must in India, and reiterated without any ambiguity whatsoever that, to facilitate this process, his government may bring in a legal framework under which doctors will have to prescribe generic medicines.

Immediately following its wide coverage by both the national and international media, many eyebrows were raised regarding the feasibility of the intent of the Indian Prime Minister, especially by the pharma industry and its business associates, for the reasons known to many. A somewhat muted echo of the same could be sensed from some business dailies too, a few expressed through editorials, and the rest quoting the views on the likely ‘health disaster’ that may follow, if ‘branded generics’ are not prescribed by the medical profession. Obviously, the main apprehension was centered around the ‘shoddy quality parameters’ of unbranded generic drugs in India. It’s a different matter though, that none can possibly either confirm or pooh-pooh it, backed by irrefutable data with statistical significance.

Be that as it may, making high quality generic drugs accessible to most patients at affordable prices, avoiding any possible nexus between the doctors and pharma companies, which could jeopardize the patients’ economic interest, deserves general appreciation, shrill voices of some vested interests notwithstanding.  Nonetheless, if the related proposals in the new pharma policy come to fruition as such, it would be a watershed decision of the government, leaving a long-lasting impact both on the patients, as well as the industry, though in different ways, altogether.

I raised this issue in my article titled, “Is Department of Pharmaceuticals On The same Page As The Prime Minister?”, published in this blog on May 15, 2017. However, in today’s discussion, I shall focus only on how has the draft pharma policy 2017 proposed to address this issue, taking well into consideration the quality concerns expressed on unbranded generics, deftly.

Before I do that, let me give a brief perspective on ‘brand name drugs’, ‘generic drugs’, ‘branded generics’ and ‘unbranded generic drugs’. This would basically serve as a preamble to arrive at the relevance of ‘branded generic’ prescriptions, along with the genesis of safety concern about the use of un-branded generic drugs.

No definition in Indian drug laws:

Although, Drugs and Cosmetics Act of India 1940 defines a drug under section 3 (b), it does not provide any legal definition of ‘brand name drugs’, ‘generic drugs’, ‘branded generic drugs’ or ‘un-branded generics’.  Hence, a quick landscaping of the same, as follows, I reckon, will be important to understand the pertinence of the ongoing debate on ‘branded generic’ prescriptions in India, from the patients’ health and safety perspectives:

‘Brand name’ drugs:

Globally, ‘brand name drugs’ are known as those, which are covered by a product patent, and are usually innovative New Chemical Entity (NCE) or a New Molecular Entity (NME). Respective innovator pharma companies hold exclusive legal rights to manufacture and market the ‘brand name drugs’, without any competition till the patents expire.

Generic drugs:

Post patent expiry of, any pharma player, located anywhere in the world, is legally permitted, as defined in the Intellectual Property Rights (IPR) regulations, to manufacture, market and sell the generic equivalents of ‘brand name drugs’. However, it’s a global norm that the concerned generic manufacturer will require proving to the competent drug regulatory authorities where these will be marketed, that the generic versions are stable in all parameters, and bioequivalent to the respective original molecules. According to US-FDA, a ‘generic drug’ will require to be the same as the original ‘brand-name drug’ in dosage, safety, strength, quality, purity, the way it works, the way it is taken and the way it should be used.

‘Branded generic’ drugs:

Branded generics are generic molecules marketed and prescribed by their respective brand names. Around 90 percent of generic formulations are branded generics in India, involving heavy sales and marketing expenditure in various forms, which has become a contentious issue today in India. The reason being, although branded generics cost significantly more than unbranded generics, the former variety of generic drugs are most preferred by the medical profession, as a group, in India. Interestingly, there is no difference whatsoever in the marketing approval process between the ‘branded generics’ and other generic varieties without any brand names.

Unbranded generic drugs:

Unbranded generic drugs are those, which are sold only in the generic names, sans any brand name. I reiterate, once again, that there is no difference in the marketing approval process between the ‘branded generics’ and ‘unbranded generic medicines’.

The core issue:

The whole debate or concern related to both efficacy and safety on the use of unbranded generic drugs in India stems from a single regulatory issue, which is widely construed as scientifically improper, and totally avoidable. If this subject is addressed in a holistic way and implemented satisfactorily in the country, by and large, there should not be any worthwhile concern in prescribing or consuming single ingredient unbranded generic drugs in India, which generally cost much less than their branded generic equivalents.

This core issue is primarily related to establishing bioequivalence (BE) with the original molecules for all generic formulations, regardless of whether these are branded or unbranded generic drugs. Thus, positive results in bioequivalence studies, should be a fundamental requirement for the grant of marketing approval of any generics in India, as is required by the regulators of most countries, across the world.

This has been lucidly articulated also in the publication of the National Institute of Health (NIH), USA, underscoring the critical importance of generic drugs in healthcare is unquestionable. The article says: “it is imperative that the pharmaceutical quality and ‘in vivo’ performance of generic drugs be reliably assessed. Because generic drugs would be interchanged with innovator products in the market place, it must be demonstrated that the safety and efficacy of generics are comparable to the safety and efficacy of the corresponding innovator drugs. Assessment of ‘interchangeability’ between the generic and the innovator product is carried out by a study of ‘in vivo’ equivalence or ‘bioequivalence’ (BE).”

The paper further highlights, “the concept of BE has, therefore, been accepted worldwide by the pharmaceutical industry and national regulatory authorities for over 20 years and is applied to new as well as generic products. As a result, thousands of high-quality generic drugs at reduced costs have become available in every corner of the globe.”

Why is BE not mandatory for marketing approval of all generic drugs in India?

It is intriguing, why is this basic scientific and medical requirement of proving BE is not mandatory for granting marketing approval of all generic drugs at all time, without any exception – covering both branded generics and their unbranded equivalents, in India.

As I have already deliberated on this subject in my article titled “Generic Drug Quality: Cacophony Masks An Important Note, Creates A Pariah ”, published in this blog on May 08, 2017, I shall now proceed further to relate this critical issue with the Draft Pharma Policy 2017.

Brand, branding and branded generics:

Nevertheless, before I focus on the draft pharma policy 2017, let me skim through the definitions of a ‘brand’ and the ‘branding process’, in general, for better understanding of the subject.

American Marketing Association defines a brand as: ‘A name, term, design, symbol, or any other feature that identifies one seller’s goods or services as distinct from other sellers.’ Whereas, ‘The Branding Journal’ articulates: ‘A brand provides consumers with a decision-making-shortcut when feeling indecisive about the same product from different companies.’

Business Dictionary describes the ‘branding process’ as: ‘Creating a unique name and image for a product in the consumers’ mind, mainly through advertising campaigns with a consistent theme. Branding aims to establish a significant and differentiated presence in the market that attracts and retains loyal customers.’

How does it benefit the branded generic consumers?

One thing that comes out clearly from the above definitions that brands, and for that matter the branding process is directed to the consumers. Applying the branding process for generic drugs, the moot question that surfaces is, how does it benefit the pharma consumers, significantly?

Besides, the branding process being so very expensive, adds significant cost to a generic drug, making its price exorbitant to most patients, quite disproportionate to incremental value, if any, that a branded generic offers over its unbranded equivalents. Thus, the relevance of the branding process for a generic drug, continues to remain a contentious issue for many, especially where the out of pocket expenditure for medicines is so high, as in India.

Marketing experts’ view on the branding process for drugs:

An interesting article titled ‘From Managing Pills to Managing Brands’, authored by the Unilever Chaired Professor of Marketing and a research fellow at INSEAD, published in the Harvard Business Review made the following observations on brands and the branding process for drugs:

“…It takes a huge investment to build a successful brand, consumer goods manufacturers try to make their brands last as long as possible. Some consumer products—notably, Coca-Cola, Nescafé, and Persil (a European laundry detergent) -  have stayed at the top for decades. That’s not to say the products don’t evolve, but the changes are presented as improvements and refinements rather than as breakthroughs.”

“In the pharmaceutical business, by contrast, a new product is always given a new name. Drug companies believe that only by introducing a new name can you signal to the market that the product itself is new. Unfortunately, this approach throws out the company’s previous marketing investment entirely; it has to build a new brand with each new product. That may not have mattered when pharmaceutical companies could rely on a large, high-margin market for each drug they wheeled out. But in a crowded market with tightening margins, the new-product, new-brand strategy is becoming less and less feasible.”

The above observations when applied to expensive ‘branded generics’, which are nothing but exact ‘me too’ varieties among tens other similar formulations of the same generic molecule, do not add any additional value to the patients, in a well-functioning drug regulatory environment.

Hence, to reduce the out of pocket drug cost significantly, Prime Minister Modi hinted at bringing an appropriate legal framework to address this critical issue, which gets well-reflected in the draft pharma policy 2017, as I read it.

Six key features of the draft pharma policy related to ‘branded generics’:

Following are the six key features enshrined in the draft pharma policy 2017 to translate into reality what the Prime Minister spoke about on this subject in Surat on April 17, 2017.

1. Bio-availability and Bio-equivalence tests mandatory for all drug manufacturing permissions:

For quality control of generic drugs, Bio-availability and Bio-equivalence tests (BA/BE Tests) will be made mandatory for all drug manufacturing permissions accorded by the State Drug Regulator or by the Central Drug Regulator. This will be made compulsory even for the future renewals of manufacturing licenses for all.

2. WHO GMP/GLP mandatory for all drug units:

The government shall ensure to get the World Health Organization’s Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) adopted by all manufacturing units.

3. No branded generics for single ingredient off-patent molecules:

The government will pursue the policy of sale of single ingredient drugs by their pharmacopeial name/salt name. To keep the identity of the manufacturer, the manufacturer would be allowed to stamp its name on the drug package. For patented drugs and Fixed Dose Combination (FDCs) drugs the brand names may be used.

4. ‘One company – one drug – one brand name – one price’:

The principle of ‘one company – one drug – one brand name – one price’ would be implemented for all drugs.

5. Aid and assistance to prescribe in generic names:

To aid and assist the registered medical practitioners in prescribing medicines in the generic names, e-prescription will be put into operation whereby the prescriptions will be computerized and the medicine name will be picked up from a drop-down menu of salt names.

6. UCPMP to be made mandatory:

The marketing practices of several pharmaceutical companies create an unfair advantage. To provide a level playing field, the regulation for marketing practices which is at present voluntary will be made mandatory. Penalty will be levied for violations and an agency for implementation would also be assigned.

Conclusion:

I have focused in this article only on those specific intents of the government, as captured in the draft pharma policy 2017, to reduce the out of pocket expenses on drugs for the Indian patients, which is currently one of the highest in the world. This area assumes greater importance to many, keeping in mind what Prime Minister Modi hinted at in this regard on April 17, 2017. If implemented exactly as detailed in the policy draft, this specific area would have a watershed impact both on the patients, as well as, the pharma companies, including their related business associates, lasting over a long period time.

Far reaching consequential fall outs are expected to loom large on the way pharma players’ strategic business processes generally revolve round ‘branded generics’ in India. I hope, the Plan B of many predominantly branded generic players is also receiving final touches on the drawing board by now, as this aspect of the draft policy proposal can in no way be construed as a bolt from the blue, catching the industry totally off-guard. That said, would the same changes as proposed in the draft pharma policy 2017, if and when implemented, be a ‘wow’ moment for patients?

By: Tapan J. Ray 

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

 

Nutraceuticals: Still An Oasis Amidst Well-Regulated Pharmaceuticals

Posted on by
Reply

On November 24, 2016, the food-safety watchdog of India announced that health supplements or Nutraceuticals cannot be sold as ‘medicines’ anymore. This new regulatory standard has been set for the manufacturers of Nutraceuticals and food supplements, and is aimed at controlling mislabeling of such brands. The fine prints of the notification are yet to be assessed.

On the face of it, this new announcement seems to be a good step, and would largely address a long-standing issue on the such products. Prevailing undesirable practices of labeling some pharma brands as food supplements or Nutraceuticals, with some tweaking in the formulations, mainly to avoid the risk of price control, is also expected to be taken care of by the food-safety authority of India, while granting marketing approval.

Nevertheless, it is often construed that off-label therapeutic claims, while promoting these products to the doctors, help achieving brand positioning objective as medicines, though indirectly. Appropriate authorities in India should probably resolve this issue, expeditiously.

In this article, I shall focus on the rationale behind different concerns over the general quality standards, claimed efficacy and safety profile of Nutraceuticals and food supplements, in general, and how the regulatory authorities are responding to all these, slowly, albeit in piecemeal, but surely.

The ‘gray space’ is the issue:

The close association between nutrition and health has assumed a historical relevance. Growing pieces of evidence, even today, suggests that nutritional intervention with natural substances could play an important role, especially in preventive health care. The World Health Organization (WHO) has also highlighted that mortality rate due to nutrition related factors in the developing countries, like India, is nearly 40 percent.

However, as one of the global consulting firm of repute has aptly pointed out, “At one end of this natural nutrition spectrum, are functional foods and beverages as well as dietary supplements, aimed primarily at maintaining health. On the other, more medical end of the spectrum, are products aimed at people with special nutritional needs. In the middle, is an emerging gray area of products that have a physiological effect to reduce known risk factors, such as high cholesterol, or appear to slow or prevent the progression of common diseases such as diabetes, dementia or age related muscle loss.”

This gray space between Pharmaceutical and Nutraceuticals, therefore, holds a significant business relevance, from various perspectives.

An Oasis amidst highly-regulated pharmaceuticals:

Mostly because of this gray space, several pharma companies and analysts seem to perceive the Nutraceutical segment virtually an oasis, lacking any transparent regulatory guidelines, amidst well-regulated pharma business. This perception is likely to continue, at least, for some more time.

Such pattern can be witnessed both within the local and global pharma companies, with some differences in approach, that I shall deliberate later in this article.

However, regulators in many countries, including India, have started expressing concerns on such unfettered manufacturing, marketing and other claims of Nutraceuticals. Many of them even ask, do all these Nutraceuticals deliver high product quality, claimed effectiveness and safety profile to their consumers, especially when, these are promoted by several pharma companies, though mostly off-label, to generate physicians’ prescriptions for various disease treatments?

Not just domestic pharma companies:

This concern is not restricted to the domestic companies in India.

Global pharma players, who generally believe in scientific evidence based medicines, have been reflecting an iffiness towards Nutraceuticals. For example, whereas both Pfizer and Novartis reportedly hived off their nutrition businesses, later Pfizer invested to acquire Danish vitamins company Ferrosan and the U.S. dietary supplements maker Alacer. Similarly, both Sanofi and GlaxoSmithKline also reportedly invested in mineral supplements businesses that could probably pave the way of the company’s entry into medical foods.

However, it is worth underscoring that generally the consumer arms of global pharma companies focus on OTC, and Nutraceuticals do not become an integral part of the pharma business, as is common in India.

Interestingly, not very long ago, Indian pharma industry witnessed a global pharma major virtually replicating the local marketing model involving Nutraceuticals. It also became an international news. On August 24, 2011, ‘Wall Street Journal (WSJ)’ reported that ‘Aventis Pharma Ltd. (now Sanofi India) agreed to buy the branded nutrition pharmaceuticals business of privately held Universal Medicare Pvt. Ltd for an undisclosed amount, as its French parent Sanofi looks to expand in the fast-growing Indian market.’

Universal Medicare, which posted about US$ 24.1 million revenue in the year ended March 31, 2011, will manufacture these branded Nutraceutical products and Aventis will source them from Universal Medicare on mutually agreed terms. Around 750 of the Universal Medicare’s employees also moved to the French Company along with its around 40 Nutraceutical brands, the report said.

If all these acquired brands, do not fall under the new FSSAI guidelines related to the required composition of food supplements and Nutraceuticals in India, it would be worth watching what follows and how.

Nutraceuticals are also promoted to doctors:

Let me reemphasize, India seems to be slightly different in the way most of the pharma companies promote Nutraceuticals in the country. Here, one can find very few standalone ‘Over the Counter (OTC)’ pharma or Nutraceutical product company. For this reason, Nutraceutical brands owned by the pharma companies, usually become an integral part of their prescription product-portfolio. Mostly, through off-label promotion Nutraceuticals are often marketed for the treatment or prevention of many serious diseases, and promoted to the doctors just as any other generic pharma brand.

Need to generate more scientific data based evidences:

A 2014 study of the well-known global consulting firms A.T. Kearney titled, “Nutraceuticals: The Front Line of the Battle for Consumer Health”, also recommended that ‘a solid regulatory framework is crucial for medical credibility, as it ensures high-quality products that can be relied on to do what they say they do.’

This is mainly because, Nutraceuticals are not generally regarded by the scientific community as evidence based medicinal products, going through the rigors of stringent clinical trials, including pharmacokinetics and pharmacodynamics studies, and is largely based on anecdotal evidence. Besides inadequacy in well-documented efficacy studies, even in the areas of overall safety in different age groups, other side-effects, drug interactions and contraindications, there aren’t adequate scientific evidence based data available to Nutraceutical manufacturers, marketers, prescribers and consumers.

There does not seem to be any structured Pharmacovigilance study is in place, either, to record adverse events. In this scenario, even the ardent consumers may neither realize, nor accept that Nutraceuticals can cause any serious adverse effects, whatsoever.

From this angle, the research study titled, “Emergency Department Visits for Adverse Events Related to Dietary Supplements”, published in the  New England Journal of Medicine (NEJM) on October 15, 2015, becomes very relevant. The paper concluded as follows:

“More than 23,000 emergency department visits annually in the United States from 2004 through 2013 were for adverse events associated with dietary supplements. Such visits commonly involved cardiovascular adverse effects from weight-loss or energy herbal products among young adults, unsupervised ingestion of micronutrients by children, and swallowing problems associated with micronutrients among older adults. These findings can help target interventions to reduce the risk of adverse events associated with the use of dietary supplements.”

Fast growing Nutraceutical industry continues to remain largely unregulated. It persists, even after several previous studies had revealed dangerous levels of harmful ingredients, including amphetamine, in some Nutraceuticals.

Indian regulatory scenario:

In India, the ‘Food Safety and Standards Authority of India (FSSAI)’, established under the Food Safety and Standard Act of 2006, is the designated Government body responsible for the regulation and approval of Nutraceuticals in the country.

In July 2015, FSSAI proposed draft regulations for Nutraceuticals, Functional Foods, Novel Foods and Health Supplements for comments from all stakeholders within the stipulated time limit. This draft regulation defines Nutraceuticals as follows:

“Nutraceuticals means a naturally occurring chemical compound having a physiological benefit or provide protection against chronic disease, isolated and purified from food or non-food source and may be prepared and marketed in the food-format of granules, powder, tablet, capsule, liquid or gel and may be packed in sachet, ampoule, bottle, etc. and to be taken as measured unit quantities.”

In this draft FSSAI also proposed that therapeutic claims of Nutraceuticals and all such foods are required to be based on sound medical and nutritional evidence, backed by scientific as well as clinical evidence.

In 2011, FSSAI constituted a product approval committee, whose members were supposed to use similar parameters as drugs, to assess Nutraceuticals for this purpose. However, FSSAI had to jettison this idea, in compliance with the order dated August 19, 2015 of the Supreme Court questioning the procedure followed for approvals by the food regulator.

In April 2016, FSSAI restricted enforcement activity against Nutraceuticals and health supplement companies to only testing of products till new standards are notified.

The latest regulatory developments:

There are, at least, the following two recent developments reflect that the regulatory authorities, though trying, but are still grappling with the overall product quality, efficacy and safety concerns for Nutraceuticals:

  • Responding to the growing demand for regulatory intervention in this important matter, on November 30, 2015, by a gazette notification, the Government of India included phytopharmaceutical drugs under a separate definition in the Drugs & Cosmetics (Eighth Amendment) Rules, 2015, effective that date.
  • Again, on November 24, 2016, FSSAI reportedly announced that health supplements or Nutraceuticals cannot be sold as ‘medicines’ anymore. This new regulatory standard set for the manufacturers of Nutraceuticals and food supplements is aimed at controlling mislabeling of such brands. On its enforcement, every package of health supplement should carry the words ‘health supplement’ as well as an advisory warning ‘not for medicinal use’ prominently printed on it.

It further added: “The quantity of nutrients added to the articles of food shall not exceed the recommended daily allowance as specified by the Indian Council of Medical Research and in case such standards are not specified, the standards laid down by the international food standards body namely the Codex Alimentarius Commission shall apply.”

However, these regulations will be enforced from January 2018.

Curiously, in September 2016, National Institutes of Health in United States announced plans to put some more scientific eyes on the industry, the NIH reportedly announced plans to spend US$ 35 million to study natural products, ranging from hops to red wine’s resveratrol to grape seed extract. The new grants, reportedly, are expected to fathom the basic science behind many claims that Nutraceuticals can improve health.

The market:

The August 2015 report titled, ‘Indian Nutraceuticals, Herbals, and Functional Foods Industry: Emerging on Global Map,’ jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and the consulting firm RNCOS, estimates that the global Nutraceuticals market is expected to cross US$ 262.9 billion by 2020 from the current level of US$ 182.6 billion growing at Compound Annual Growth Rate (CAGR) of about 8 percent.

Driven by the rising level of awareness of health, fitness and changing lifestyle pattern, increasing co-prescription with regular drugs, and focus on preventive health care, India’s Nutraceuticals market is likely to cross US$ 6.1 billion by 2020 from the current level of US$ 2.8 billion growing at CAGR of about 17 percent, the report states.

The United States (US) has the largest market for the Nutraceuticals, followed by Asia-Pacific and European Union. Functional food is the fastest growing segment in the US Nutraceutical market, followed by Germany, France, UK and Italy in Europe.

Conclusion:

Today, both manufacturing and marketing of Nutraceuticals keep charting in a very relaxed regulatory space, in India. There are no robust and transparent guidelines, still in place, for product standardization and scientifically evaluate the safety and efficacy of all these products on an ongoing basis. Neither is there any stringent requirement for conformance to the well-crafted cGMP standards.

The reported discussions within the Union Ministry of Ayush for setting up a structured regulatory framework, within the CDSCO, for all Ayush drugs and to allow marketing of any new Ayurvedic medicine only after successful completion of clinical trials to ensure its safety and efficacy, are indeed encouraging. This may be followed for all those Nutraceuticals, which want to be promoted as medicines, claiming direct therapeutic benefits.

Be that as it may, November 24, 2016 announcement of FSSAI, that health supplements or Nutraceuticals cannot be sold as ‘medicines’ anymore to control mislabeling of such brands, is a step in the right direction.

Another major issue of many pharma brands being put under Nutraceuticals with some tweaking in formulations and labelled as food supplements, would also probably be largely addressed, as FSSAI would continue to be the sole authority for marketing approval of Nutraceuticals.

However, it is still not very clear to me, as I am writing this article, what happens to those Nutraceutical brands, which are already in the market, with compositions not conforming to the new FSSAI norms. Fairness demands reformulation and relabeling of all those existing Nutraceuticals, strictly in conformance to the new guidelines, and obtain fresh approval from FSSAI. This will help create a level playing field for all Nutraceutical players in India.

While there is a pressing need to enforce a holistic regulatory discipline for the Nutraceuticals to protect consumers’ health interest, the commercial interest of such product manufacturers shouldn’t be ignored, either. This is primarily because, there exists enough evidence that proper nutritional intervention with the right kind of natural substances in the right dosage form, could play an important role, especially in the preventive health care.

As the comprehensive regulatory guidelines are put in place, Nutraceuticals not being essential medicines, should always be kept outside price control, in any guise or form. In that process, the general pharma perception of Nutraceutical business, as an ‘Oasis’ amidst well-regulated and price-controlled pharmaceuticals, would possibly remain that way, giving a much-needed and well-deserved boost to this business.

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.

Does Healthcare Feature In Raisina Hill’s To-Do List?

Posted on by
Reply

At the Capitol Hill, while addressing the joint session of the United States Congress, on June 08, 2016, our Prime Minister Mr. Narendra Modi well articulated the following, in his inimitable style:

“My to-do list is long and ambitious. It includes a vibrant rural economy with robust farm sector; a roof over each head and electricity to all households; to skill millions of our youth; build 100 smart cities; have a broadband for a billion, and connect our villages to the digital world; and create a 21st century rail, road and port infrastructure.”

This ambitious list is indeed praiseworthy. However, as the Prime Minister did not mention anything about health care infrastructure, while referring to rapid infrastructure development in India, it is not abundantly clear, just yet, whether this critical area finds a place in his ‘to-do’ list, as well, for ‘We The People of India’.

This apprehension is primarily because, no large scale, visible and concrete reform measures are taking place in this area, even during the last two years. It of course includes, any significant escalation in the public expenditure for health.

Ongoing economic cost of significant loss in productive years:

“The disease burden of non-communicable diseases has increased to 60 per cent. India is estimated to lose US$ 4.8 Trillion between 2012 and 2030 due to non-communicable disorders. It is therefore critical for India to transform its healthcare sector,” – says a 2015 KPMG report titled, ‘Healthcare: The neglected GDP driver.’ 

This significant and ongoing loss in productive years continues even today in India, handicapped by suboptimal health care infrastructure, and its delivery mechanisms. Such a situation can’t possibly be taken for granted for too long. Today’s aspiring general public wants the new political leadership at the helm of affairs in the country to address it, sooner. A larger dosage of hope, and assurances may not cut much ice, any longer.

Transparent, comprehensive, and game changing health reforms, supported by the requisite financial and other resources, should now be translated into reality. A sharp increase in public investments, in the budgetary provision, for healthy lives of a vast majority of Indian population, would send an appropriate signal to all.

As the above KPMG report also suggests: “It is high time that we realize the significance of healthcare as an economic development opportunity for national as well as state level.”

Pump-priming public health investments:

With a meager public expenditure of just around 1.2 percent of the GDP on health even during the last two years, instead of rubbing shoulders with the global big brothers in the health care area too, India would continue to rank at the very bottom.

Consequently, the gaping hole within the healthcare space of the country would stand out, even more visibly, as a sore thumb, escaping the notice, and the agony of possibly none.

With around 68 percent of the country’s population living in the rural areas, having frugal or even no immediate emergency healthcare facilities, India seems to be heading towards a major socioeconomic imbalance, with its possible consequences, despite the country’s natural demographic dividend.

According to published reports, there is still a shortage of 32 and 23 percent of the Community Health Centers (CHC) and the Primary Health Centers (PHC), respectively, in India. To meet the standard of the World Health Organization (WHO), India would need minimum another 500,000 hospital beds, requiring an investment of US$ 50 Billion.

Moreover, to date, mostly the private healthcare institutions, and medical professionals are engaged in the delivery of the secondary and tertiary care, concentrated mostly in metro cities and larger towns. This makes rural healthcare further challenging. Pump-priming public investments, together with transparent incentive provisions for both global and local healthcare investors, would help augmenting the process.

Help propel GDP growth:

As the above KPMG report says, the healthcare sector has the ability to propel GDP growth via multiple spokes, directly and indirectly. It offers a chance to create millions of job opportunities that can not only support the Indian GDP growth, but also support other sectors of the economy by improving both demand and supply of a productive healthy workforce.

Three key areas of healthcare:

Healthcare, irrespective of whether it is primary, secondary or tertiary, has three major components, as follows: 

  • Prevention
  • Diagnosis
  • Treatment 

Leveraging digital technology:

As it appears, leveraging digital technology effectively, would help to bridge the health care gap and inequality considerably, especially in the first two of the above three areas.

A June 06, 2016 paper titled, ‘Promoting Rural Health Care: Role of telemedicine,’ published by the multi-industry trade organization -The Associated Chambers of Commerce and Industry of India (ASSOCHAM) said: “With limited resources and a large rural population telemedicine has the potential to revolutionize the delivery of healthcare in India.”

As the report highlighted, it would help faster diagnosis of ailments, partly address the issues of inadequacy of health care providers in rural areas, and also the huge amount of time that is now being spent in physically reaching the urban health facilities. Maintenance of the status quo, would continue making the rural populace more vulnerable in the health care space, than their urban counterparts.

The study forecasted that India’s telemedicine market, which has been growing at a compounded annual growth rate (CAGR) of over 20 per cent, holds the potential to cross US$32 million mark in turnover by 2020, from the current level of over US$15 million.

According to another report, currently, with around 70 percent overall use of smartphones, it is quite possible to give a major technology enabled thrust for disease prevention, together with emergency care, to a large section of the society.  

However, to demonstrate the real technology leveraged progress in this area, the Government would require to actively help fixing the requisite hardware, software, bandwidth and connectivity related critical issues, effectively. These will also facilitate keeping mobile, and other electronic health records.

Disease treatment with medicines:

To make quality drugs available at affordable prices, the Indian Government announced a new scheme (Yojana) named as ‘Pradhan Mantri Jan Aushadhi Yojana’, effective July 2015, with private participation. This is a renamed scheme of the earlier version, which was launched in 2008. Under the new ‘Pradhan Mantri Jan Aushadhi Yojana’, about 500 generic medicines will be made available at affordable prices. For that purpose, the government is expected to open 3000 ‘Jan Aushadhi’ stores across the country in the next one year i.e. 2016-17.

The question now is what purpose would this much hyped scheme serve?

What purpose would ‘Pradhan Mantri Jan Aushadhi Yojana’ serve?

Since the generic drugs available from ‘Jan Aushadhi’ retail outlets are predominantly prescription medicines, patients would necessarily require a doctor’s physical prescription to buy those products.

In India, as the doctors prescribe mostly branded generics, including those from a large number of the Government hospitals, the only way to make ‘Jan Aushadhi’ drugs available to patients, is to legally allow the retailers substituting the higher priced branded generic molecules with their lower priced equivalents, sans any brand name.

Moving towards this direction, the Ministry of Health had reportedly submitted a proposal to the Drug Technical Advisory Board (DTAB) to the Drug Controller General of India (DCGI), for consideration. Wherein, the Ministry reportedly suggested an amendment of Rule 65 of the Drugs and Cosmetics Rules, 1945 to enable the retail chemists substituting a branded drug formulation with its cheaper equivalent, containing the same generic ingredient, in the same strength and the dosage form, with or without a brand name.

However, in the 71st meeting of the DTAB held on May 13, 2016, its members reportedly turned down that proposal of the ministry. DTAB apparently felt that given the structure of the Indian retail pharmaceutical market, the practical impact of this recommendation may be limited.

For this reason, the ‘Pradhan Mantri Jan Aushadhi Yojana’, appears to be not so well thought out, and a one-off ‘making feel good’ type of a scheme. It is still unclear how would the needy patients derive any benefit from this announcement.

Conclusion:

On June 20, 2016, while maintaining the old policy of 100 per cent FDI in the pharmaceutical sector, Prime Minister Modi announced his Government’s decision to allow foreign investors to pick up to 74 per cent equity in domestic pharma companies through the automatic route.

This announcement, although is intended to brighten the prospects for higher foreign portfolio and overseas company investment in the Indian drug firms, is unlikely to have any significant impact, if at all, on the prevailing abysmal health care environment of the country.

Hopefully, with the development of 100 ‘smart cities’ in India, with 24×7 broadband, Wi-Fi connectivity, telemedicine would be a reality in improving access to affordable healthcare, at least, for the population residing in and around those areas.

Still the fundamental question remains: What happens to the remaining vast majority of the rural population of India? What about their health care? Poorly thought out, and apparently superficial ‘Pradhan Mantri Jan Aushadhi Yojana’ won’t be able to help this population, either. 

With the National Health Policy 2015 draft still to see the light of the day in its final form, the path ahead for healthcare in India is still rather hazy, if not worrying. 

As stated before, in the Prime Minister’s recent speech delivered at the ‘Capitol Hill’ of the United States earlier this month, development of a robust healthcare infrastructure in the country did not find any mention in his ‘to-do’ list.

Leaving aside the ‘Capitol Hill’ for now, considering the grave impact of health care on the economic progress of India, shouldn’t the ‘Raisina Hill’ start pushing the envelope, placing it in one of the top positions of the national ‘to-do’ list, only to protect the health interest of ‘We The People of India’?

By: Tapan J. Ray

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

Just 16% Of Indian Population Has Access To Free Or Partially-Free Health Care?

Posted on by
Reply

Is health care currently a low priority area for the Government of India? Probably yes, and thus it is worth trying to fathom it out.

Besides planned frugal spending on overall public health in 2015-16, even as compared to the past trend, two other health related budgetary decisions of the Government are indeed baffling, at the very least.

As many of you, I too know that the incumbent Government in its first full-year budget of 2015-16 has sharply reduced the budgetary allocation on many important health related other projects, such as:

- Union budget allocation for the National Rural Drinking Water Program (NRDWP) that aims at providing safe drinking water to 20,000 villages and hamlets across India, has been drastically reduced this year. Curiously, this decision has been taken at a time, when India loses 200 million person days and Rs 36,600 crore every year due to water-related diseases.

- The Integrated Child Development Services (ICDS) scheme, which provides food, preschool education, and primary health care to children under 6 years of age and their mothers, has also been hit by a 54.19 percent budget cut this year. This decision too of cutting public expenditure on food, nutrition and health care for children to more than half, defies any logic, especially when 40 percent of growth stunted children in the world are reportedly from India, exceeding the number of even sub-Saharan Africa.

I hasten to add that the Union budget 2015-16 has indicated, as the states’ share in the net proceeds of the union tax revenues has increased, as per recommendations of the 14th Finance Commission, these central Government programs will now be run with a changed funding pattern between the Union and states. However, according to financial experts in these areas, regardless of devolution, the total money available to run these critical projects is sharply decreasing.

That said, on the other pages of the same Union Budget, public funding in the current fiscal year for bridges and roads has more than doubled. The budgetary allocation for these two areas now stands more than even education.

I deliberated on similar subject of access to health care in my blog of March 16, 2015, titled, “With Frugal Public Resource Allocation Quo Vadis Healthcare in India?”

Health care sector is important for job creation too:

According to the World Health Organization (WHO), health care sector is one of the largest job creators, not just in India, but globally. Thus, Indian health care industry being one of the fastest growing industrial turf in the country with a reasonable base, deserves a sharper focus of the Government.

Additionally, the socio-economic benefits that this sector provides in creating a sustainable, healthy and highly productive work force, has been well documented and can’t just be wished away, in any case.

The neglect is intriguing:

Currently, total healthcare spend of India is no more than 4.2 percent of the GDP with public spending being just 1.2 percent of it. Other BRICS nations are way ahead of India, in this area too. To set a direction on country’s public healthcare spend, breaking the jinx of a long period of time, the draft National Health Policy 2015 of the Government aimed at initial increase in health expenditure to 2 percent of the GDP.

As a result of the legacy of neglect over a long period of time, which continues albeit more blatantly even today, only 16 percent of the Indian population declares today that they have access to free or partially-free health care. I shall dwell on this area subsequently in this article.

Keeping these in perspective, it was intriguing, when the union budgetary allocation for health care in 2015-16 was kept at Rs. 297 billion or U$4.81 billion for its main health department, almost the same outlay as in the previous budget.

When compared against public fund allocations, such as, US$ 93 billion for highway projects or US$ 7.53 billion for 100 smart cities in the country, one will get a realistic perspective of this meager health budget allocation, in terms of effectively addressing the health care needs of around 1.25 billion people of India. Over 70 percent of this population live in the hinterland.

Agreed that the Government focus on these ‘infrastructure projects’ are not unimportant by any means. Nevertheless, the above comparison only highlights how much priority the Government assigns to the health care sector of India and for the health of its citizens. This issue assumes even greater significance in combating several challenging health situations, such as, ongoing fight against increasing incidence of life-long chronic ailments and deadly life-threatening diseases like, cancer, fueling already high rate of morbidity and mortality in the high country.

A quick glimpse on a few outcomes of neglect:

The Working Paper No. 1184 dated January 8, 2015, titled “Improving Health Outcomes And Health Care In India” of the Organization for Economic Co-operation and Development (OECD), highlights some interesting points, as follows:

  • Chronic diseases are the biggest causes of death and disability accounting for 50 percent of deaths, with cardiovascular diseases and diabetes, respiratory conditions and cancers figuring most prominently.
  • Preventive interventions such as improving access to a clean water supply, reducing the spread of HIV/AIDS through better sexual education, and vaccination campaigns for other diseases will each deliver more significant returns in life years.
  • Vaccination rates for diphtheria, tetanus and pertussis, for measles and for hepatitis B are all much lower than in OECD and peer countries.
  • Minimal access to free or partially-free health care.

It is an irony that ‘life expectancy’ in India still remains well below the countries at a similar level of development.

Abysmal overall hygienic conditions:

The OECD survey brings to the fore  abysmal hygienic conditions still prevailing in India. It can only be improved through active intervention of the Government with necessary budgetary allocations, sans photo ops for some celebrities and most politicians. Sincere support and participation of the civil society and intelligentsia, in general, are also equally important.

The paper underscores, among others, the following extremely unhygienic conditions still prevailing both in urban and rural India:

  • Most households in rural India do not defecate in a toilet or latrine, which leads to infant and child diseases (such as diarrhea) and can account for much of the variation in average child height. Even today the sight of poor children defecating openly in the streets, that too in a city like Mumbai, is also not very uncommon.
  • The burning of solid fuels in particular (undertaken by more than 80 percent of the population in cooking) is a major risk factor behind ischemic heart disease, lower-respiratory tract infections and chronic obstructive pulmonary diseases and could also increase cataracts and stroke.
  • Exposure to air pollution is a significant problem.
  • Many of the poor continue to smoke heavily.
  • 11 of the lowest income quintile did not undertake sufficient physical activity, compared with 16 percent in the highest income quintile.

India provides minimal access to free or partially-free health care:

As I mentioned above, India provides minimal access to free or partially-free healthcare to its citizens, as compared to all the BRICS nations, many other countries in South East Asia and even in Africa.

The above OECD paper states that with poor health intertwined with poverty, the greatest gains lie with policies that address the social conditions which enable combating communicable and non-communicable diseases.

Among BRICS countries, India provides least access to ‘Free or Partially-Free Health Care’ Services to its general population. This is despite being the largest democracy in the world, which is now striving hard to emerge as an economic and military superpowers.

The following study shows that only 16 percent of the Indian population declares having access to free or partially-free health care from the government:

BRICS Countries % surveyed said ‘Yes’ to the question: “Does your household have access to free or partially free health care from the State”
India 16
Brazil 24
China 73
Russia 96
South Africa 62

Source: Credit Suisse Research Institute, Emerging Consumer Survey Databook 2014.

As the OECD paper states, in this study approximately 1500 respondents were surveyed in each country, with India and China both having larger sample size of 2500. The male-to-female split between respondents was roughly 50:50 in all cases with rural-to-urban split varying by country.

Poor satisfaction level with existing health care services:

This is very important; as public facilities are the predominant source of qualified health professionals in rural areas where much of the Indian poor reside. In addition, significant population growth is occurring in urban slums, where urban public health care facilities are struggling to provide basic services. In a situation like this, slum dwellers face challenging economic barriers to accessing expensive private health care services (MoHFW, 2012).

The OECD survey indicates that 41 percent of those in rural areas and 45 percent in urban areas were not satisfied with treatment by their doctors or facility.

The reason attributed to this dissatisfaction are as follows:

  • Distance was cited by 21 percent of people in rural areas and 14 percent in urban areas.
  • Public health care centers remain closed more than half the time and lack basic medical supplies, such as stethoscopes and blood pressure scales.
  • Non-availability of required services was cited by 30 percent of people in rural areas and 26 percent in urban areas.

This is quite credible, as according to the Government’s own estimates:

- 10 percent of primary health care centers are without a doctor

- 37 percent are without a laboratory technician

- 25 percent without a pharmacist (MoHFW, 2012)

The above picture is quite consistent with large scale surveys in poor communities of India, by OECD.

Health care business for up market is booming:

Growing inequitable distribution of healthcare products and services is now wide open and blatant, more than ever before. There is no signal yet that the Government would soon consider health care sector as its one of the key focus areas, along with education, just as infrastructure, such as, building roads, highways, e-highways, flyovers, bridges and smart cities.

For up-market patients, the private sector is creating world class facilities in India. We can see today a good number of ‘five-star’ hospitals, with more number of newer ones coming up offering jaw-dropping facilities, quite akin to, may be even surpassing what are being offered for patients’ luxurious comfort in the developed world. Although these facilities cost a fortune, one would usually need to be in a queue to get admitted there for any medical or surgical treatment.

Most of these hospitals are now in high demand for ‘medical tourism’. According to available reports India currently caters to health care needs of over 200,000 foreign patients. ‘Medical tourism’ business reportedly fetched around US$ 2 billion to India in 2012.

On the flip side of it, as we all read in the recent media reports, some of these hospitals in Delhi refused admission even to seriously ill dengue patients, as they can’t afford such facilities. A few of these patients ultimately succumbed to the disease and the parents of one such poor child, who died without any hospital treatment in that process, committed suicide unable to withstand the irreparable and tragic loss.

Giving ‘Infrastructure Status’ to health care sector:

When creating basic infrastructure is the priority area of the present Government for financial resource allocation, why not give ‘infrastructure status’ to the health care sector now? This is not just for the heck of it, but purely based on merit and earlier detail evaluation by a Government Committee of experts.

To address the critical health care needs for the vast Indian population with appropriate infrastructure, quality products, services and manpower, providing ‘infrastructure status’ to the health care sector could facilitate the whole process. Additionally, it can transform the Indian healthcare sector as one of the biggest job-generating industry too.

This has been a key demand of the industry until recently, though not so much being talked about it today. A few years back, the previous Government was reportedly mulling to assign full fledged infrastructure status to the healthcare sector, as it merits inclusion in the category of ‘infrastructure’, satisfying all the nine criteria set by the erstwhile Rangarajan Committee.

I find in my archive, the Confederation of Indian Industry (CII) also demanded ‘infrastructure status’ for the health care sector in its pre-union budget memorandum for 2010-11. In that proposal CII had estimated that health care industry in India requires an investment of around US$80 billion, whereas in the current fiscal year the public expenditure on health still languishes at U$4.81 billion.

This specific issue seems to have taken a back seat today, for reasons not known to me. However, it is interesting to note that not just the Government apathy, no such demand is being made today by the large multi-industry trade associations of India, as vociferously as we witness, for example, in the case of ‘The Goods and Service Tax (GST) Bill’.

Health care debate is not to the fore today:

Critical health care issues of the country don’t seem to be in the fore front today for comprehensive debates even for the Indian main stream media, to influence the government.

We have been experiencing for quite while that Indian media, including social media, in general, usually goes ballistic 24×7 mostly with selective sensational topics. These may include, among others…glitzy events on Government’s high profile advocacy initiatives to attract more Foreign Direct Investment (FDI) from large overseas companies…Or back home some unfortunate and tragic Dengue fever related deaths due to negligence just in Delhi, though the same and equally grave incidences taking place in the other states of India, are hardly getting any coverage…Or on some high profile alleged murder pot-boilers announcing media verdict conclusively, even before completion of police investigation and charge-sheet being filed in a court of law.

These are probably neither bad, nor unimportant, nor avoidable, nor can come within the ambit of any media criticism. I am also not trying to do that, either.

As the saying goes, variety is the spice of life. We, therefore, generally want to get a feel of it everyday early in the morning, mostly glancing through the newspaper headlines, or in the late evening watching impatient anchor with strong personal opinion trying hard to dominate over all other participants in high-decibel ‘TV debates’, as these are called by the respective channels.

In an era of sensationalized and eye-ball grabbing ‘Breaking News’ of all kinds, flashing everywhere almost every now and then, critical health care issues seem to have become a mundane subject to the newsmakers for any meaningful debate to influence the Government. Serious debates on critical health care issues presumably would not generate all important Television Rating Points (TRPs) to the TV channel owners. Though I have no idea, the TRP of such debates  probably has been estimated to be even lesser as compared to the cacophony aired by the TV channels on the cost to exchequer for the MPs subsidized meals in the Indian Parliament…with intermittent high pitch ‘war cry’ of the dominating anchor… ‘the nation wants to know this’.

Conclusion:

Be that as it may, health care environment impacts all of us, quite appreciably. There is not even an iota of doubt on it. However, we can feel it mostly when the reality hits us or our families hard…very hard, as serious and cruel ailments strike suddenly, or as we face avoidable disease related deaths of our near and dear ones, or when illness makes a loving one virtually incapacitated, even after facing financial bankruptcy.

Health care is a serious matter for all of us, just as it is a serious and critical business for every nation and every Government. This criticality factor is independent of whatever level of economic development the country is aspiring for. Thus, the indifference of the Indian Government, if I may say so, despite promising so much on health care earlier this year, is intriguing, and more so, when just 16 percent of the total population has access to free or partially-free health care in our India of the 21st century.

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.