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The Recent Ban On Irrational FDCs: History Repeats Itself

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The recent regulatory ban on a large number of irrational Fixed Dose Combination (FDC) drugs is not a new incident in India. A similar mega ban was announced even before, about nine years ago. Intriguingly, the saga continues, for various reasons, without any tangible outcome for the patients on the ground.

On March 11, 2016, the latest ban, again on a large number of irrational FDCs, was notified. It caused a flutter and an immediate sharp adrenaline rush to the impacted drug companies and was soon followed by an interim stay order, again by an honorable High Court of the country.

Thus, when I connect the past dots with the latest one, on mega ban of irrational FDCs in India, a similar sequence of events gets unfolded, following each of such ban notifications of the Government.

Looking back, 294 FDCs were banned by the DCGI in 2007. At that time too, the important issue of patients’ health, safety and economical interest, got converted into a legal quagmire. Many adversely affected FDC drug players chose to go to the court of law to protect their business interest, and also successfully managed to obtain a ‘Stay’ order from the Madras High Court.

Consequently, those 294 irrational FDCs, banned by the Union Ministry of Health on health and safety grounds, continued to be promoted, prescribed and sold to patients across India, without any hindrance, whatsoever.

The matter continues to remain sub judice, as we deliberate the issue here. Thus, whether the recent gazette notification on the ban of irrational FDCs would immediately be implemented, unlike the past ban, or the history would repeat itself, is indeed a big question mark, at this juncture.

Would this ban have similar outcome?  

As discussed, close to a decade after the serious legal fall-out of the ban of 294 irrational FDCs in 2007, another mega ban of 344 irrational FDCs has been announced by the Government, through a Gazette Notification dated March 11, 2016. Some well known brands, such as, Corex, Phensedyl, Crocin Cold and Flu, D-Cold Total, Nasivion and Vicks Action 500 Extra, among others, reportedly come under this ban now. Here is the complete list of 344 banned FDCs.

According to the Government, the reason for banning these drugs is that ‘they involve risk to humans and safer alternatives were available.’

Nevertheless, manufacturers of some of these mega brands have again obtained an interim injunction on the ban for their respective products, from the Delhi High Court.

Sometime during the day, i.e. on March 21, 2016, the honorable Delhi High Court is expected to take up this patient-centric issue. It apparently smacks a blatant self-serving interest of the concerned irrational FDC manufacturers, that defeats the core purpose and value of pharma products for their users.

Like most other issues, the Court directive on this issue, as well, would ultimately prevail, without any shade of doubt.

Is it a ‘bolt from the blue’ for the pharma industry? 

Many industry watchers feel that this recent ban has not come as a ‘bolt from the blue’ for the pharma players, at all, as is being claimed by a section of the pharma industry. Even the Union Ministry of Health has, reportedly, clarified the following points on the recent notification:

  • “We have tried to bring objectivity to the issue by roping in the best of scientists to study the effects of these FDCs.”
  • “Show cause notices were also issued to more than 344 companies and they were given time to make further representations after the expert committee gave their recommendations. Some of them did not even care to respond. Everybody was given ample opportunity. After that, the move was initiated. It was done after much examination.”
  • “It is necessary and expedient in the public interest to regulate by way of prohibition of manufacture for sale, sale and distribution for human use, of the said drugs in the country.”

It is worth noting, at least, one of these well known pharma brands was, reportedly, banned in one of our neighboring countries – Sri Lanka, in 2012, for wide-spread drug misuse, long after its marketing approval in the country.

Some key events leading to the recent ban: 

Besides the above articulation by the Union Ministry of Health, it is worth noting, especially, the following key developments to ascertain, whether this ban came suddenly to the irrational FDC manufacturers, and without any prior warning or appropriate communication:

  • The issue of manufacturing licenses being granted by some states for FDCs without prior approval of Central Drugs Standard Control Organization (CDSCO), was first discussed by the Drugs Technical Advisory Board (DTAB) in the year 2000, though without any major tangible outcome till 2007. 
  • In 2007, Government banned 294 FDCs, and the consequent court proceedings had ‘Stayed’ this ban.
  • Expressing huge concern on pharma malpractices related to irrational FDCs, the Parliamentary Standing Committee on Health and Family Welfare in its 59th report (2012) also had flagged this issue. The lawmakers observed in the report that manufacturing licenses for large numbers FDCs were being issued by the State Drug Authorities, without prior approval of the Central Drugs Standard Control Organization (CDSCO), in violation of rules. The committee also noted that multiple FDCs, which are available in India had been rejected by the drug regulators in Europe, North America, and Australia, while for many others never had marketing approval applications submitted outside India (Section 7 of [6]).
  • Subsequently, in June 2013, CDSCO  announced the “Policy Guidelines for Approval of Fixed Dose Combinations (FDCs) In India.”
  • According to CDSCO, just 1193 FDCs were approved by the DCGI, since 1961 till November, 2014. Thus, all drug manufacturers should clearly know, which FDC has been approved by the DCGI, and when, leaving no scope for any ambiguity in this area. Thus, there should be no problem in total conformance to the above ‘FDC Policy Guidelines’ by these drug producers.
  • In the same year – 2013, a public notice was also, reportedly, issued, calling all those drug players manufacturing FDCs to apply with the requisite fee, in the prescribed form to the DCGI office, providing the required details.  
  • In 2014, a six-member committee, chaired by Prof. (Dr.) Chandrakant Kokate, Vice Chancellor, KLE University, Jawaharlal Nehru Medical College, Belgaum, Karnataka, was formed to expedite the review process of the applications. 
  • The Kokate Committee has, reportedly, reviewed about 6,600 FDCs, so far, and classified them under four categories – irrational, require further deliberations, rational and require additional data generation. 
  • According to a report, 963 FDCs were found under the irrational category, providing reasons in detail for each. 
  • In 2016, the Government finalized its action, based on the Report of Kokate Committee and also the response received (or still not received despite requests) from the concerned FDC manufacturers.
  • The March 11, 2016 Gazette Notification banned 344 ‘irrational’ FDCs, ruffling many feathers, but understandably to protect patients’ health interest.
  • On March 14, 2016, in response to an appeal against this ban through a writ petition, first by Pfizer, the Delhi High Court reportedly granted the company a stay, pending the next court hearing on March 21, 2016. Subsequently, several such stay orders by the honorable Delhi High Court have been issued with the same date of hearing. 
Adverse health and economic impact on patients:

Besides serious health risks, the patients also suffer from a huge adverse economical impact, in rupee value terms, by consuming much avoidable irrational FDC formulations, which are generally more expensive than single ingredient drugs, if taken separately at times of necessity or convenience.

The ban of 344 FDCs is estimated to cover over 2,500 brands, in different therapy categories, including chronic diseases, where medicines are taken for a long period of time. Thus, a large number of patients were consuming these irrational formulations for a long period of time without any inkling of their necessity and more importantly serious adverse health impact that these irrational FDCs could cause.

To quantify how much have the patients collectively spent on these banned medicines, in the rupee value terms, I shall quote from the estimates of one of the well reputed and much quoted pharma retail audit and market research organization of India – AIOCD Pharmasofttech AWACS Pvt. Ltd.

According to its report of March 13, 2016, Indian Pharmaceutical Industry would lose Rs. 3,838 Crore (MAT), which is 3.1 percent of the turnover of the Indian Pharmaceutical Market (IPM), when calculated based on the retail sales of these FDCs in the last 12-month period.

Paraphrasing the same finding, one can logically conclude that Indian patients withstood an adverse economic impact of Rs. 3,838 Crore in a 12-month period, by spending on these unnecessary and irrational FDCs of dubious value, besides health risks. 

To my surprise, some of the MNC pharma players contribute a major chunk to this avoidable expenditure of the patients, besides associating and avoidable health risks.

Quoting similar credible data, it is also possible to give company-wise break-up in this area, which, in my view, may not be meaningful here.

Two Critical issues to address:

Although, a lot of water has since flown down the bridges, a large number of irrational FDCs are still in the market, exposing patients to possible health hazards and economical hardship.

In this blog, I discussed this core issue in two of my articles, one on July 15, 2013 titled, “FDC Saga: Defiant Manufacturers, Sloppy Regulators and Humongous Inaction”, and the other on May 18, 2015 titled, “Booming Sales Of Unapproved Drugs: Do We Need ‘Safe In India’ Campaign For Medicines?”.

I reckon, the following two would still remain the critical issues, which need to be addressed, expeditiously, once and for all, for patients’ sake: 

  • Stringent compliance with the latest CDSCO requirements by all the manufacturers of FDCs in India must be ensured. Any non-conformance should attract strong punitive measures, through a transparent process.
  • Whether such drugs are being widely misused, creating a grave risk for health and other safety hazards, must be ascertained periodically, based on credible data.
An important example:                         

Just the other day, Reuters reported that one of the largest pharma companies operating in India, was selling a FDC of the antibiotics cefixime and azithromycin, without approval of the DCGI.

Interestingly, this particular FDC has reportedly not received marketing approval in the major global pharma markets, such as, the United States, the United Kingdom, Germany, France or Japan.

After the ban of this irrational FDC, the company was compelled to stop manufacturing and sales of this powerful antibiotic cocktail that poses huge health risk to patients.

This Reuters report also states, the drug ‘had been promoted and administered as a treatment for a broad array of illnesses, including colds, fevers, urinary tract infections, drug-resistant typhoid and sexually transmitted diseases.’ It also found chemists who were selling the drug to prevent post-operative infection and for respiratory problems.

Many doctors and health experts have been saying that the spread and misuse of antibiotic combinations may be contributing to antibiotic resistance in India.

FDC approval must be hard evidence-based:

Since all pharmaceutical products, whether available as a single ingredient, or FDC formulations, are globally considered as ‘Evidence-Based Medicines’. Such evidences are established through robust, stringent and well regulated clinical trials for obtaining marketing approval from the drug regulators, unlike most ‘traditional medicines’.

Following this well-established global norm, and as recommended by even the World Health Organization (WHO), all irrational FDCs must be identified through a transparent and medical science-based process, and banned forthwith by the Government.

Establishing safety and efficacy for all FDCs through clinical trials, just like any other single ingredient drug, introduced for the first time in India, whenever it happens or had happened in the past, inadvertently or otherwise, should be a ‘must happen’ regulatory requirement, for all time to come.

Profit making interest through introduction of a plethora of irrational FDCs, should never be allowed to overshadow patients’ health and economical interest.

The bogey of even ‘25 to 30-year-old FDCs’ now being banned: 

Some section of the industry is also raising this point, vociferously, protesting against the bans of their respective old and top-selling FDC brands, which have now been considered by the Government as irrational, and questioning: ‘why now?’

This point is irrelevant, as not taking action ever, against a wrong doing allowed over a long period time, does not make an irrational FDC formulation a rational one, for all time to come.

Moreover, this recent action of the drug regulator can not be considered as unique either. With the advancement of medical science, in the past years too, the DCGI issued banned notifications, covering many old FDCs, considering those ‘irrational combinations’ at a given point of time, such as, analgin + pitofenone, vitamins B1 + B6 + B12, cyproheptadine + lysine, just to name a few.

Conclusion:

As is known to many, pharmacovigilance is still at a very nascent stage in India. Consequently, ‘Adverse Drug Reactions (ADR)’ or ‘Adverse Drug Events’ reporting are still abysmally poor in the country. No information on ‘Adverse Drug Events’, as claimed by the manufacturers of these irrational FDCs, should, therefore, in no way mean that these drugs are safe and efficacious and beyond any reasonable doubt.

Although the laxity of the drug regulator in this area can’t also be condoned, in any way, the enormity of the risks posed by irrational FDCs to the innocent patients, is indeed mind boggling.

If the manufacturing and sale of all irrational FDCs are not legally stopped, even after a long and rigorous scientific and medical scrutiny by the experts, the patients in the country would, unfairly, continue to remain exposed to huge health and economic risks, without any fault of theirs. This is exactly what happened in 2007 also, when, after the stay order of the ban notification for 294 irrational FDCs by the honorable Madras High Court, all those FDCs continued to be promoted, prescribed and sold to patients across India, unhindered… but at whose cost?

Yet again, the gazette notification of the Government on the recent ban on 344 FDCs, has gone for judicial scrutiny, at least, for some money spinning key brands of the large pharma players.

This time, however, there is one significant difference, the Government seems to be far more assertive and committed to ensure that only safe medicines are available in the market, despite reported intense advocacy by the industry. This commitment on the part of the Government is also evident from the media report that the (DGCI) has again sent a new list of additional 1,200 FDCs for a probe to the panel, which recommended the ban of 344 irrational FDCs in the last week, and that too, after the court stay order on the latest ban.

Further, a senior a senior official in the Health Ministry has, reportedly, reiterated that the Government will stand firm on its decision, and will support the ban with robust data, in the Delhi High Court.

Would history repeat itself, this time now? We, at least, would get a sense of it, as the proceeding of the honorable Delhi High Court commences today, on this issue.

Either way, it will possibly send a clear signal, whether the triumph of commercial profit motive with irrational FDCs would continue, unabated, over patients’ health, safety and economic interests, at least in the foreseeable future. 

By: Tapan J. Ray

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

 

Health Care: “India Has Moved From Strength To Strength!”

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The above flabbergasting assertion came recently from the Union Government of India in context of current health care system in the country. 

To be specific, this proclamation of the Ministry of Health was reportedly made at its ‘point by point rebuttal’ letter to the world’s leading medical journal of high repute - ‘The Lancet’, at the end of October 2015, in response to a news report on India’s frugal public expenditure on health. 

The chronicle:

On October 21, 2015 The Times Of India reported that shortly, a detail study in “The Lancet” would take Prime Minister Narendra Modi to task for failing in make public health a national priority area. It is happening despite his categorical promise of rolling out ‘Universal Health Coverage (UHC), during the last general election of India, in 2014.

The paper would be penned by some of the world’s foremost health experts and the issue is expected to be published on December 11, 2015.

In an interview with ‘The Times of India’, Richard Horton - the Editor-in- Chief of ‘The Lancet’, said that “health is an issue of national security for India, but Modi isn’t taking it seriously.”

Horton further commented, “I don’t see any new policies, any new ideas, any significant public commitment, and most importantly no financial commitment to the health sector, since he came into power in May, 2014.”

According to Norton, since Modi has come to power, health has completely lost focus of the Government. India is on the edge in this regard. If Prime Minister Modi does not tackle health, India’s economy combined with rising population is not sustainable. “The country’s healthcare system will collapse, if the government fails to invest in combating non-communicable diseases, such as, diabetes and heart problems”, he cautioned.

‘The Lancet’ to present contemporary fact-based analysis:                         

It is expected that the above article on India’s prevailing public health system, would be factual and analyzed based on the latest expert survey in this regard.

As I mentioned in my article of October 5, 2015 in this Blog titled, “Just 16% Of Indian Population Has Access To Free Or Partially-Free Health Care?”, the current Government has slashed union budgets for several ongoing and critical flag-ship schemes for health, such as:

  • Integrated Child Development Services
  • Mid-day meal
  • Aids and STD control
  • National Food Security Mission
  • National Rural Drinking Water Program

After a drastic reduction in union budgetary allocations for these crucial and very basic health schemes, there would possibly be no scope for any surprise in any quarter, if ‘The Lancet’ survey depicts a rather dismal overall public health care scenario in India.

Indian Government trashes ‘The Editor-in-Chief’s comment:

Trashing ‘The Lancet’ Editor-in-Chief’s above comments, Rakesh Kumar, Joint Secretary, Ministry of Health in a hard-hitting letter to Horton reportedly said:

“…launching an alphabet soup of program every quarter and not being able to implement them in true letter and spirit is a disservice to the people we serve.” 

According to this news report, the health ministry maintained that “no existing program” of the ministry has been “curtailed, stopped or truncated due to lack of funds”. It also highlighted that funding to states had been rationalized to break from the straight jacket of ‘one size fits all’ geographies and populations.

“India has moved from strength to strength and some of recent initiatives will ensure improved outcomes for the most vulnerable,” the letter re-iterated unequivocally.

“India has moved from strength to strength” – Government retorted: 

The above statement of the Union Ministry of Health that “India has moved from strength to strength” in health care, generally sounds bizarre and also absurd, to say the least. On the contrary, the available facts do not support this sweeping comment, as it were.

When compared with some much smaller neighboring nations of India and even Vietnam, it comes out clearly that they are doing far better on various critical health indicators.

This is vindicated by the ‘World Bank health indicators data’, which show that even Bangladesh, Nepal and Vietnam, with much lesser per capita GDP, are ahead of India in several key health indicators, as shown in the following table: 

Some Key Indicators India Bangladesh Nepal Vietnam
GDP Per capita(PPP) (Constant at 2011 US$) 2014 5445 2981 2261 5370
Life Expectancy At Birth (Female) 2013 68 71 70 80
Survival to Age 65 (% of Cohort) 2013 63 72 69 72
Public Health Expenditure (% of GDP) 2013 1.3 1.3 2.6 2.5
Infant Female Mortality Rate (Per 1000 Live Births) 2015 38 28 27 15
Mortality Rate (Under 5 year of Live Births) 2015 48 38 36 22
Maternal Mortality Ratio (per 1000 Live Births) 2013 190 170 190 49
Rural Population With Improved Access to Sanitation Facilities (%) 2015 29 62 44 70
Vitamin A Supplementation Coverage Rate (% of Children 6-59 months) 2013 53 97 99 98
Immunization DPT (% of Children 12-23 month) 2014 83 95 92 95

(Source: Live Mint, October 28, 2015)

Similarly, another 2011 study published in the ‘The Lancet’ reported that ‘Out of Pocket’ expenditure on health in India is the highest, again even as compared to its much smaller neighbors, as follows:

Country Out of Pocket Expenditure on Health (%)
Maldives 14
Bhutan 29
Sri Lanka 53
India 78

As I said before, these are just a few examples. In this article, I shall not dwell further on such comparisons, which are already known to many. 

Instead, I would prefer to underscore, as many scholarly research papers have already done, that GDP growth of a nation cannot be driven in a sustainable manner without putting in place a robust public health care system in a country. 

Reasonable public investment is necessary to improve health indicators:

If India wants to improve its key health indicators and surpass the achievements of just not smaller countries, such as, Nepal, Bangladesh, Sri Lanka, Maldives, but all other BRICS (Brazil, Russia, China and South Africa) nations, India needs to hike up its public health budget significantly, together with speedy implementation of all identified health projects.

According to the World Bank 2004 report (p56), for developing or middle-income countries with institutions of an acceptable quality, a 10 percent increase in public health expenditures as a proportion of the GDP, would be associated with a 7 percent decrease in the maternal mortality rate, a 0.69 percent decrease in child mortality rate, and a 4.14 percent decrease in low weight for children under five years of age.

Impact of health on economic growth shouldn’t be underestimated:

Between ‘public health’ and ‘other economic growth drivers’, choosing just one as priority focus area, could well be futile, in the long run. This is by no means an ‘either/or’ situation, at all. The Government should take into cognizance that there is a heavy price tag attached on an underestimation of the impact of health on economic growth, which could put its core objective of a sustainable high GDP growth in jeopardy.

I would now illustrate this point with no more than three examples, out of so many available.                                                                                   

According to the ‘World Health Organization (WHO)’, “Good health is linked to economic growth through higher labor productivity, demographic changes and higher educational attainment. In the same way, poor health undermines economic growth.”  

India, though, seems to be chasing a high economic growth with all guns blazing, apparently does not believe in this fundamental dictum; neither does the Government accept that current public health care system is generally pathetic in the country and virtually on the verge of crumbling, if inaction continues.

To underscore the same point that impact of health on the economy should not be underestimated, I now quote from another study hereunder.

A December 2012 paper published in the “Global Management Journal” titled, “The Connection Between Health and Economic Growth: Policy Implications Re-Examined”, concluded as follows: 

“Evidence presented in this paper illuminates the two-way relationship between economic growth and health. Bearing in mind the substantial influence of enhanced health to economic productivity and growth, governments need to look at health expenses as an investment rather than a cost”.

My third example would be another paper published in ‘OECD Observer’ titled, “Health and the economy: A vital relationship”, written by Julio Frenk, Mexican Minister of Health and Chair of the 2004 meeting of OECD Health Ministers. This paper too reiterates that the impact of health on the economy should not be underestimated. Thus, our challenge today is to harmonize health and economic policies to improve health outcomes.

Julio Frenk further emphasized, “The effects of health on development are clear. Countries with weak health and education conditions find it harder to achieve sustained growth. Indeed, economic evidence confirms that a 10% improvement in life expectancy at birth is associated with a rise in economic growth of some 0.3-0.4 percentage points a year.”

Here comes the critical importance of improving ‘Human Development Index (HDI)’ ranking of India to achieve a high and sustainable GDP growth, as the nation moves on.

 Improve ‘Ease of doing business’ and ‘Human development’ indices together: 

According to ‘World Bank’s Doing Business Report 2016’, India has moved up four rungs in the global rankings for ‘ease of doing business’. The country now ranks 130 among 189 countries, against its last year’s ranking of 134. This is a significant achievement, which has been widely publicized by the Government and very rightly so. 

Whereas, according to the latest (2014) ‘Human Development Index (HDI) report, published annually by the ‘United Nations Development Program (UNDP)’, India ranks 135 out of 187 countries across the world. The next HDI report is expected to be launched in November 2015.

HDI is a statistical tool used to measure a country’s overall achievement in its social and economic dimensions. It captures a composite statistic of life expectancy, education, and per capita income indicators, which are used to rank countries into four tiers of human development.

Increase in life expectancy is a composite outcome of long-term effectiveness of a robust public health care system in the country.

Interestingly, the present Government does not talk much about HDI. Its primary focus seems to be now on ‘ease of doing business’, though for a sustainable high economic growth of a nation both should be speeded up and right in tandem. 

Conclusion: 

Reducing Union Budget allocation on health substantially and passing the responsibility of the same to the States with no assigned accountability for implementation on the ground, may not work in India. 

Even if the comments of Richard Horton, the Editor-in-Chief of ‘The Lancet’ on this score, are brushed aside with contempt, his factual observations should be noted as valid suggestions. Accordingly, much required action steps need to be factored in by the Government in its 20116-17 Union Budget planning process.

Before concluding, I would very humbly, respectfully and with all humility submit that the Union Government should always be open to outside experts’ comments and suggestions, especially on public health in the country, to initiate a constructive debate. Any voice of discord or dissent, either on Governments’s action or inaction or both, may not necessarily be construed as an act against the national interest.

In this context, I am curious to know, what happened when on October 19, 2015, the Union Cabinet Minister for Women and Child Welfare – Mrs. Maneka Gandhi, who oversees a scheme to feed more than 100 million poor people, reportedly expressed her anguish and concerns in public. She openly said that slashing of her Ministry’s budget by half to US$1.6 billion, has hit her plans to strengthen the fight against ‘Child Malnutrition’ and makes it difficult to pay wages of 2.7 million of health workers.

Leave aside ‘The Lancet’ squabble for a moment. Does the above public anguish of a senior Union Cabinet Minister, in any way, depict that “India has moved from strength to strength” in health care?

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.

Health Care in India: Disrupt The Status Quo

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Over decades, we have been trying to ferret out the unfeigned reasons of failure for India to provide access to reasonably affordable, quality health care to all its citizens, but in vain. The quest to know its rationale becomes more intense, as we get to know, even some developing countries in Asia, Africa and Middle East are taking rapid strides to catch up with the health care standards of the developed countries of the world.

In the last few years many such countries, such as, Thailand, Turkey, Rwanda and Ghana, besides China, have successfully ensured access to quality and affordable healthcare to their citizens through well-structured national initiatives. Governments of economically poorer countries, such as, Sri Lanka and Bangladesh too are making rapid progress in this direction. All these commendable health care initiatives are protecting the most vulnerable populations in their respective countries from getting swept away by extreme poverty.

No more than just assurances:

In India, economic and social costs of public health care infrastructural inadequacy, consequent low access and inefficient delivery mechanism keep going north, unabated, barring a small number of States. Over decades, Union Governments of all political dispensations have been making no more than incoherent promises and that too in bits and pieces on reform in public health care services. As on date, no Union Government has articulated a comprehensive pathway to achieve this goal, in tandem with the States, specifying required time-frames and making commensurate budgetary allocations.

Despite the legacy factor, the incumbent Government as well, has not taken any tangible measure in this direction, just yet, besides giving similar in-coherent assurances. Nor has it clearly articulated that providing access to quality health care for all, at a reasonable cost, is one of its top areas of priority in the widely publicized ‘National Development Agenda’.

Agonizing wait continues:

That the Government is now in the process of drafting a National Health Policy to meet the rising demand for sustainable healthcare across the country, was announced by the Secretary – Health & Family Welfare on September 1, 2014. The first draft of The National Health Policy 2015 was placed in the public domain seeking inputs from the stakeholders in January 2015.

That said, agonizing wait of the patients with unfathomable patience still continues for better days of high quality and affordable health care services in India. Palpable feeling of long standing apathy of the decision makers in this area keep lingering simultaneously.

Two critical admissions:

Besides others, following are the two critical and unambiguous admissions in the draft National Health Policy 2015:

  • “The failure to attain minimum levels of public health expenditure remains the single most important constraint.”
  • “Over 63 million persons are faced with poverty every year due to health care costs alone, it is because there is no financial protection for the vast majority of health care needs.”

In my article of January 12, 2015 published in this Blog, titled “National Health Policy 2015 Needs Wings To Fly ”, I deliberated on the draft National Health Policy 2015.

No commensurate budgetary provisions:

Despite being aware of the above facts, the Union Budget for 2015-16 allocated just below Rs. 30,000 Crore for health care in India, without unveiling any longer term picture in this regard, not even a ‘broad brush’ one.

To give a perspective regarding how meagre is this budgetary allocation on so critical an area, I quickly add that on August 19, 2015, Prime Minister Modi announced an allocation of Rs.1.25 lakh crore for the development of only Bihar, just prior to the state going for the assembly election.

Untenable reason:

The Finance Ministers reasoned in his budget speech that post devolution of resources to the states following the recommendations of the 14th Finance Commission, the states will address the issue of healthcare in their respective geographical jurisditions.

However, it does not make much sense to me, if at all. This is mainly because, though health is a state subject, it is still a very critical national issue with an overall dismal performance of the country against most of the ‘Millennium Development Goals’.

Only a ‘National Health Plan’ funded jointly and adequately by both the center and the States with clear budgetary provisions and executed immaculately against clearly measurable performance parameters with specifically assigned accountabilities, could salvage the disastrous consequences of further neglect in the health care space of the country.

Not just deployment of financial resources:

The core issue, I reckon, is not just inadequate deployment of financial resources, but continuation of lack of effective governance in the Union Ministry of Health, as well. And, this is indeed a deadly combination. It has been pushing a large number of patients in India embracing abject poverty every year, as admitted in the draft National Health Policy 2015 of the incumbent Government, but with no visible rectifying measures, as on date.

Dangling carrots, as it were, to the patients by different Union Governments in shedloads, such as, ‘free medicines for all’, ‘free health insurance for all’, ‘free diagnostics for all” and what not ‘for all’, has been continuing forever, with patients having no other choices but to have patience in plenty and probably in perpetuity.

When Primary Health Care itself is a critical issue… :

In such deteriorating heath care environment, when primary health care still remains a key issue mostly in rural India, yet another interesting and tentative assurance reportedly comes from no less than the Union Minister of Health himself on August 18, 2015, when he said:

“The government is working both in secondary and tertiary medical sector and I believe that we need to work out a module in PPP mode to lessen the healthcare burden of common man.”

Having said that, when it comes to providing healthcare services to the poor and the needy, the Honorable Minister, expressed his vision in a notably interesting way, which is reportedly as follows:

“How will we be able to give the healthcare facility to helpless is one question that is unanswered…. All stakeholders should answer this question. Enhance the teaching, the training should be at much higher, speed, scale and skill and above all there should be better communication.”

Going beyond just allopathic treatment:

To answer the Health Minister’s above question – “How will we be able to give the healthcare facility to helpless”, one of the many important ways for the Government, I reckon, is to make a decisive and robust move much beyond Allopathic treatment, just as what China has done with its ‘traditional medicines’.

The strengths of traditional Indian medicines need to be properly leveraged with requisite intervention of science and technology and supported by effective awareness building campaigns.

Expand the role of ‘Traditional Medicines’:

Treatment with traditional medicines in India for many well-tried common diseases, has the potential to play an important role in providing access to health care for all, at least in the public health care space of the country, where AYUSH (Ayurveda, Yoga, Unani, Siddha and Homoeopathy) needs to be promoted and encouraged, actively.

It is expected that the new National Health Policy 2015 would have a much greater focus on the traditional systems of medicine – AYUSH, for the treatment of many common diseases.

It appears from various reports, AYUSH system that calls for not very sophisticated technological inputs for diagnosis of common diseases and preparation of medicinal substances, could be made an integral part of the entire healthcare spectrum, starting from the primary health centers.

As a basic preparatory measure to achieve this goal, the rejuvenated ‘Department of AYUSH’ should work, in consultation with the respective domain experts, to chart out an effective and implementable pathway for the development of education and research in Ayurveda, Yoga, Naturopathy, Unani, Siddha, and Homeopathy systems.

Need to increase focus on AYUSH:

It has been widely reported that the use of herbs to treat various common ailments is almost universal among many societies, as these are quite often more affordable than buying expensive modern allopathic medicines.

According to the World Health Organization, around 80 per cent of the population of some Asian and African countries currently use traditional medicines to address their health care needs.

I thought the same holds good for India, as well.

However, from a very recent and credible survey report, I find that the above impression is not quite true for India. Penetration of traditional AYUSH systems of treatment, even within the rural population of India, is currently abysmally low.

According to NSSO’s (National Sample Survey Office) Household Expenditures on Health Survey, conducted between January and June 2014, usage of Allopathy for “spells of ailment” is unusually high both in urban and rural India, as follows:

Category Allopathy Treatment %
Rural Males 90.6
Rural Females 88.7
Urban Males 90.4
Urban Female 91.0

(Source: NSSO 2014-15)

In the absence of adequate access to safe and cost-effective treatments through public health care infrastructure and delivery systems, be it Allopathic or AYUSH, more number of patients are compelled to seek expensive private healthcare services for their “spells of ailment”, as follows:

Category Private Doctors Private Hospitals
Male 51.3 24.3
Female 49.7 23.9

(Source: NSSO 2014-15)

AYUSH could play an important role to address such issues, appreciably.

An intriguing recent media report:

On August 19, 2015, I read an intriguing media report that highlights the following two points on apparently a ‘recently overhauled draft’ of the National Health Policy 2015, as follows:

  • “The National Democratic Alliance (NDA) government plans to increase public investment in health from 1.04 per cent of GDP (gross domestic product) to 2.5 per cent by 2020, with 70 per cent of this being dedicated to primary health care. This target has been set in the overhauled draft National Health Policy that now emphasizes on substantially ratcheting up government investment in public health care facilities across the country.”
  • “Of the total funds required, the Union government would provide 40 per cent, which could be shored up through a health cess on the lines of an education cess. The cess fund to be used specifically for public health investments could be partly shored up by imposing additional duties on tobacco, alcohol, fatty, salty and sugary products that are considered unhealthy by experts.”

Why is this media report so baffling?

This news really baffled me…a lot, as another more than six month old media report of January 1, 2015 stated just the same on the same two points, exactly quoting the very first draft (not the ‘overhauled’ one) of the National Health Policy 2015 , as follows:

  • “The draft National Health Policy, 2015 has proposed a target of raising public health expenditure to 2.5 % from the present 1.2% of GDP. It also notes that 40% of this would need to come from central expenditure.”
  • “The government is also keen to explore the creation of a health cess on the lines of education cess for raising money needed to fund the expenditure it would entail. Other than general taxation, this cess could mobilize contributions from specific commodity taxes such as the taxes on tobacco, and alcohol, from specific industries and innovative forms of resource mobilization.”

Be that as it may, I would urge you to please read both the old and new original media reports on the same draft National Health Policy 2015 and draw your own conclusions, as you deem appropriate.

No change on the ground:

The media reports, such as above, elaborately detailing a significant increase in the health care expenditure as a percentage of GDP in the so called “overhauled” draft of the National Health Policy 2015, gave me an impression that the status quo, at least, in the public health care expenditure scenario has now been disrupted, which in reality has not, at all.

Such reports make patients continue ‘counting colors in the rainbow’, as it were. They keep expecting that getting access to quality and affordable health care for all would soon become a reality, with the Government thinking afresh to raise the public health care expenditure significantly. In reality, the status quo on the ground continues and it can’t be just wished away.

Deserves ‘Infrastructure Status’:

To achieve the basic health care goals of the nation, the Government would require to set the national priorities right. Health care has to be placed at the top rungs of its ‘National Development Agenda’ just as ‘infrastructure’- disrupting the prevailing status quo.

Considering its critical social and economic impact on the progress of the nation, it is about time that ‘Health Care Sector’ be given the ‘infrastructure status’ in India, not just to give a further boost to the industry, but also to make health care products and services affordable to all.

Conclusion:

Making health a ‘Fundamental Right’ for Indian Citizens, as narrated in the draft National Health Policy (NHP) 2015 of Narendra Modi Government, is indeed profound in its both content and intent. However, inordinate delay in its finalization and commencement of implementation process is rather disturbing.

Overhaul and expansion of public health care infrastructure, services and the effective delivery mechanism, undoubtedly, are very necessary requirements for the length and breadth of the country, excepting a very small number of states, which are doing so well in this area.

That said, the real issue is much more deep seated. As the well-known economist Subir Gokarn wrote in one of his articles that in health care “the consequence of inaction is a vicious circle between morbidity and poverty.”

This ‘vicious circle’ has to be broken, sooner. Many developing countries, including much poorer nations, have successfully demonstrated that access to basic quality healthcare can be provided to all, at an affordable cost.

Well-crafted robust national health care plan and policy, which are integrated with similar initiatives of the States should soon be put in place. Effective implementation of a comprehensive, well-integrated and time-bound health care strategic plan, with requisite budgetary allocations and periodic review, assigning specific accountabilities to individuals, are the needs of the hour. Otherwise, the social and economic consequences of the status quo in the health care space of India, would impede the sustainable growth of the nation, seriously.

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.