Tag Archives: Health

Drug Pricing Pressure to Escalate Further?

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On February 09, 2018, NITI Aayog released its “Healthy States, Progressive India” Report. The study ranked the States based on ‘health index’. Kerala, Punjab and Tamil Nadu featured as top three in terms of overall performance in 2015-16. However, the interstate variation of ‘health indices’ was quite significant, with the highest being 76.55 (Kerala) and the lowest in Uttar Pradesh with 33.69, during the same period.

Importantly, the report also noted: “About one-third of the States have registered a decline in their performance in 2016 as compared to 2015, stressing the need to pursue domain-specific, targeted interventions.” It’s worth noting, the reported decline in performance was registered despite several promises of the Government in this space, during immediately preceding years.

Apparently, as a corrective measure to this effect, the world’s largest government-funded health care program – the ‘National Health Protection Scheme (HPS)’ of India was announced in the Union Budget Proposal, on February 01, 2018. HPS is expected to provide insurance cover of up to ₹500,000 to 100 million poor and vulnerable families, covering around 500 million population in the country.

As enshrined in the National Health Policy 2017 (NHP 2017), HPS too seeks to ensure improved access and affordability of quality secondary and tertiary care services with a significant reduction in Out of Pocket Expenditure (OOPE) on health care, for the common citizens in the country.

Such a massive public health care program as HPS, is obviously expected to use a transparent drug procurement and logistics framework. This, in turn, would necessitate tough price negotiations with the pharma manufacturers for the purchase of medicines, leading to significant reduction in drug prices. This is already happening in some States, like Tamil Nadu.

High OOPE on health:

According to the December 2016 report of the Union Ministry of Health and Family Welfare, of the total 64.2 percent OOPE in 2013-14, 53.46 percent was spent on medicines and 9.95 percent was spent on diagnostics, in India. 82.29 percent of the total OOP medicines expenditure and 67 percent of total OOP diagnostic expenditure was for outpatient treatment. Of the total OOPE, 15.96 percent was on traditional medicines/ AYUSH, of which equal proportion was spent on outpatient and inpatient care.

In an interview, published on December 18, 2017, the Chairman of the Insurance Regulatory and Development Authority of India (IRDAI), reportedly, also said, OOPE makes up about 62 percent of all health care costs in India, causing impoverishment of many patients. In a comparative yardstick, OOPE is about 20 percent in the U.S. and the U.K. and 20-25 percent in BRICS countries. Thus, there is a need to significantly bring it down in India, he said.

Curiously, the ‘Health in India’ report, which draws data from the 71st round of the National Sample Survey conducted from January to June 2014, presents a somewhat different picture. It reportedly says, of the total OOPE, 72 percent in rural and 68 percent in urban areas was towards buying medicines for non-hospitalized treatment. The Health in India report shows, in rural India, 25 percent patients relied on “borrowings” for hospitalization, and 68 percent on household income and other savings. In urban India, 18 percent patients had to borrow while admitted in hospital, and 75 percent relied on income or savings – the report further added.

Containing OOPE – a dire necessity:

Be that as it may, OOPE for health in India and, especially, on drugs, is indeed very high, by any measure. To contain this burden on the general population in the private market, the Government had introduced, since quite some time, a balancing mechanism through various Drug Price Control Orders (DPCO).

Similarly, to contain its own health care expenditure, as HPS comes into force, the Government is expected to choose a digitalized and transparent drug procurement process. This would, almost certainly, prompt tough price negotiations for the purchase of medicines, as well.

Thus, HPS may further add to the current discomfort of the pharma players in this area, as they mostly want free pricing of drugs that will only be regulated by market forces. Unfortunately, market forces do not work for drugs. I explained it in an article, published in this blog on April 27, 2015, titled “Does Free Market Economy Work For Branded Generic Drugs In India?”

Industry lobbying for free pricing of drugs and devices:

It is well known that pharma industry, supported by other businesses dependent on it, including a section of the media, is still against such a move by the Indian policy makers, for various reasons. The primary one being, such pressure on drug prices would stifle  innovation, impacting patient access to the best possible health care.

Pharma Multination Corporations (MNC) appear to be in the forefront of this ‘innovation’ bandwagon to score a brownie point in this area, as many say. This is an ongoing process for them. Even recently, in the report titled, ‘2017 Accomplishments’, the US-India Business Council’s (USIBC) made a strong assertion in this regard, quite expectedly, though.

The report articulated, as part of advocacy around price controls, USIBC had sent a letter to the National Pharmaceutical Pricing Authority (NPPA), detailing American industry concerns on setting up ceiling prices for drugs and medical devices. USIBC, reportedly has also sent a letter, expressing its concern on the “serious problems for US companies that sell these products in the Indian market.” Advocacy initiatives of this kind, reportedly included the then Foreign Secretary, Minister of Commerce and Industries of India, and the Prime Minister’s Principal Secretary, as well.

Pricing pressure getting more intense, even in the US:

Curiously, a similar and equally interesting scenario is rapidly developing alongside in the largest pharma free-market economy in the world – the United States. On January 30, 2018, during his State of the Union address, President Donald Trump said that he wants his administration “to make fixing the injustice of high drug prices one of our top priorities.”

Likewise, as reported by Bloomberg on February 09, 2018, President Trump’s Health and Human Services Secretary – Alex Azar reaffirmed that he plans to take up the President’s promises to do something about pharmaceutical prices to reduce patients’ out-of-pocket spending. He assured, “The president is firmly committed in this space.” Incidentally, Alex Azar is a former executive at drug maker Eli Lilly & Co.

HPS needs efficient public procurement and logistics mechanisms:

As the cost of drugs and devices contribute so much to the total OOPE on health, together with ensuring patients’ easy access to convenient to reach primary, secondary and tertiary health care facilities – access to drugs, devices and diagnostics for the target population of HPS must also increase, effectively. Thus, bulk procurement and distribution of these, free of cost, at the designated health centers, assumes paramount importance for its success. Consequently, the trust of the HPS beneficiaries will keep ascending.

The Public Health Foundation of India (PHFI) too, had aptly asserted, any inefficiency due to poor governance, lack of transparency and inequities in public health financing and delivery would greatly impede access to medicines and diagnostics for those who would need these most.

Admitting its importance, the NHP 2017 noted: “Quality of public procurement and logistics is a major challenge in ensuring access to free drugs and diagnostics through public facilities. An essential prerequisite that is needed to address the challenge of providing free drugs through the public sector, is a well-developed public procurement system.”

Thus, putting in place an effective framework and process for this purpose, at both the central and the state government levels, as the situation would warrant, requires to be a key priority focus area of the HPS implementation process. There doesn’t seem to be any other viable choice, either.

Any need to ‘reinvent the wheel’?

The answer is, of course, ‘no’. Perhaps, to attain similar goals, the Government had established the fully autonomous Central Medical Services Society (CMSS) as a Central Procurement Agency (CPA). This was intended to streamline drug procurement and distribution system of the Ministry of Health and Family Welfare of India. Accordingly, the Gazette Notification on the formation of CMSS said that it:

  • Will be responsible for procuring health sector goods in a transparent and cost-effective manner and distributing them to the States/UTs by setting up an IT enabled supply chain infrastructure including warehouses in 50 locations.
  • Will ensure uninterrupted supply of health-sector goods to the State Government, which will then maintain the flow to the government health facilities, such as district hospitals, primary health centers and community health centers.
  • All decisions on procurement will be taken by the CMSS without any reference to the Ministry of Health and Family Welfare.
  • The Ministry will be responsible only for policy decisions concerning procurement and for monitoring its performance.
  • The CMSS will also assist the State Governments to set up similar organizations in states to reform their procurement.

Currently, CMSS carries out procurement for following ‘Disease Control and Welfare Programs’ of the Union Ministry of Health & Family Welfare:

  • Revised National Tuberculosis Control Program (RNTCP)
  • National Vector Borne Disease Control Program (NVBDCP)
  • Family Welfare Program (FWP)
  • National Aids Control Organization (NACO)

The scope of services of CMSS includes tendering, bid Evaluation, procurement decision, concluding rate agreement, placing purchase orders, receiving in stores, sampling and testing, releasing payment to suppliers and keeping stocks of drugs available in warehouses for distribution to state program offices.

So far as State Governments are concerned, a World Bank article says, the Tamil Nadu Medical Services Corporation (TNMSC) had successfully demonstrated a cost-effective model. This IT enabled system is an integral part in the supply chain infrastructure to support the management decisions, and adequate attention to quality in drug procurement.

CMSS follows similar processes to procure and distribute supplies to States through web-connected warehouses in State capitals. An IT vendor takes up the IT work with a quality control framework in place. Its warehouses are being equipped with necessary storing and warehousing equipment, which will distribute to the States the items that are procured by the Ministry. Since the warehouses will be connected through the IT system, it will be possible for the Society to monitor the inventory in warehouses preventing stock outs and wastage.

Many State governments have also adopted a similar reform process. However, any duplication in the drug procurement and logistics systems needs to be avoided.

Conclusion:

Hence, I reckon, CMSS can be extended to the procurement process of both the new ‘Health Protection Scheme (HPS)’ and also for the ‘Health and Wellness Centers,’ without trying to ‘reinventing the wheel.’

As stated before, this seemingly transparent drug procurement process for public use, would naturally involve tough price negotiations, leading to significant reduction, not just in drug prices, but also containing the overall HPS cost to the Government, enabling the country to experience the roll out of Universal Health Coverage (UHC) for all. From this perspective, it appears, while translating into reality, this noble Government intent of providing wider access to health care, including free medicines, overall pressure on drug prices may escalate further.

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.

Union Budget 2018: The ‘WOW’ Moment for Indian Healthcare?

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The 2018-19 Union Budget proposals, presented before the Parliament on February 01, 2018. Especially for those who take keen interest in the Indian healthcare environment, was there a ‘WOW’ moment in the budget? Some say, this long-awaited moment came with the Union Finance Minister’s (FM) announcement of the ‘Ayushman Bharat Program (ABP)’ – the “world’s largest healthcare program,” taking a major step towards the Universal Health Coverage (UHC) for all, in India.

Two other health care related major announcements made by the FM in his 2018 Union Budget proposal are:

  • 24 new government medical colleges by upgrading existing district hospitals.  This is to bridge the gap between doctor-patient ratio in the country.
  • An allocation of ₹60 million for nutritional support to all tuberculosis patients – ₹ 500 per month per patient for 10 months, during the duration of their treatment.

The ‘Ayushman Bharat Program (ABP)’:

In this article, I shall not touch upon what expectations of pharma and healthcare industries were not met with the budget, as that will no more than an academic deliberation, at this stage. I shall rather restrict my discussion to ABP, for obvious reasons. This potential game changer, covers two commendable initiatives, as follows:

1. The New Health Protection Scheme (HPS) offering health insurance coverage of ₹500,000 per family per annum, is expected to take under its wings 100 million vulnerable families, or around 500 million beneficiaries. The total budgetary allocation for this mega proposal, for which the detail contours, apparently, are yet to be fleshed out and made public.

Some Senior Government officials, though, have put across its sketchy outline during post-budget Television coverage, on last Thursday. However, many industry watchers construe HPS as an expanded version, with a different name, of the current ‘Rashtriya Swasthya Bima Yojana (RSBY)’, which provides annual coverage of just ₹30,000 for poor families.

A fund of just ₹20 billion has been earmarked for this mega project in the Union Budget 2018-19.

2. Creation of 150,000 health and wellness centers to provide ‘comprehensive health care’ – for prevention and treatment of both communicable and non-communicable diseases (NCDS), including maternal/child health services, and free essential drugs alongside diagnostic services. This will “bring healthcare closer to home”, as the FM articulated.

A sum of ₹1.2 billion (₹1200 crore) had been allocated for this project in the 2018 budget proposal. The FM also requested contributions from the private sectors through CSR, besides philanthropic entities, in adopting these centers.

The points to ponder before saying ‘WOW!’

So far so good. However, as the saying goes, the devil is in the detail. From that angle, sans any meaningful details, does it look merely as an expression of the Government’ intent? Or it is for real! This serious doubt emanates from some key considerations. Three of which, as I reckon, are as follows:

I. Is it the beginning of implementation of the much-awaited National Health Policy 2017 (NHP), where the Government had committed and expenditure for UHC around 2.5 percent of the India’s GDP? This number currently hovers around 1.4 percent –  reportedly, less than even Nepal (2.3 percent) and Sri Lanka (2 percent). There is no mention of this in the Union Budget Proposal 2018, either, how much it will now go up to. By the way, the same report, as above, of January 2018 also indicated that health costs push 39 million Indians back into poverty, every year.

  • Attaining the NHP 2017 objectives, prompts a rise of around 40 percent in the public health expenditure of the Government. Whereas, the allocated reported expenditure for health in 2018-19 at ₹52.8 billion over the revised estimate of ₹50.1 billion in 2017/18. This works out to an increase of just around 5.4 percent.
  • The allocated expenditure of ₹20 billion for ABP in 2018-19, over the last year’s (2017-18) very similar health budget for ‘National Health Mission (NRM)’, reportedly, of ₹26.70 billion, looks rather pale. The financial arithmetic doesn’t appear to add up, defying simple logic. Is the allocation enough to support the ABP for 2018-19, even if the ABP funding is shared in the ratio of 60:40 between the Central and the State Governments?
  • Diving slightly deeper, on February 02, 2018, quoting a Government official Reuters reported, the cost of providing health insurance to 100 million vulnerable families or close to about half the country’s population would require an estimated ₹110 billion (USD$ 1.72 billion) in central and state funding each year.
  • The government estimates the cost of insuring each family would be about ₹1,100 rupees (US$17.15), the above report says. Curiously, on the face of it, this huge amount appears as an ‘off balance sheet’ expenditure, as of now.
  • Intriguingly, when the ABP is still not in place, there has been, reportedly, a 2.1 percent decline in the allocation towards the NRM in 2018-19. Currently, NHM provides financial support to States to strengthen the public health system, including upgradation of existing or construction of new infrastructure. In addition, there is a 7 percent cut in the allocation for the ‘Swachh Bharat Mission’ Budget from 2017-18’s revised estimates.

II. The second question is equally critical. Just as the erstwhile State Sales Tax (now a part of GST), healthcare is also a state subject. Thus, a similar process of intensive consultation with all State Governments, as happened before the implementation of GST, to take them on board, has to be replicated for a consensus. This will include a commitment for 60:40 funding, alongside the mechanisms for effective implementation of ABP – step by step. Has that happened? Have all the States agreed to contribute 40 percent of total funding requirements in their respective states for ABP?

  • If the answer is yes – excellent! If not, when will the ABP be rolled out? Different senior government officials have indicated different dates on Television. Some said on the Independence Day this year – August 15, 2018. Some other official said on October 02, 2018 – Gandhi Jayanti of this year. Yet another responsible official said the actual implementation may, actually, take even more time. This could mean only one thing, the ABP has been announced without any fixed timeframe for its implementation.

III. The third question lies in the effectiveness of insurance-driven health care system, such as in the United States. The key question often is raised on this system: Do the health insurance companies derive more benefit out of this system rather than the patients?

  • Concurring with the experts of many other countries, India’s own – Dr. (Professor) K. Srinath Reddy, globally acclaimed cardiologist and the President, Public Health Foundation of India, reportedly is also of the opinion that “Government-funded social insurance schemes do increase access to advanced care. But they have not been shown to provide financial protection as they cover only part of the hospitalization cost and none of the expense of prolonged outpatient care which forms a higher percentage of out-of-pocket spending.”
  • Insurance-driven healthcare has been found wanting to properly balancing health insurance costs with access, quality of care and outcomes in several countries. The experience of most of those people in India who can avail the benefits of insurance-driven – the Rashtriya Swasthya Bima Yojana (RSBY) or Employee State Insurance Schemes (ESIS), are not very pleasant, either.
  • On the other hand, despite some peripheral issues, many prefer, the government run UHC, such as in Britain. These generally offer a broader health coverage to all, and most health and care related services are available free to the citizens. The UHC is fully funded by taxes there, though a private health care system exists along with it. Thus, serious apprehensions related to the depth of health care access, reach in the rural heartland, and the quality of product and services to be generally provided by the insurance-driven new HPS, continue to haunt.

Conclusion:

Considering all these aspects, renamed HPS, as it was announced by the FM on February 01, 2018, and subsequent incongruent and very tentative clarifications expressed through the media by some Senior Government officials, raises even more questions than answers.

Sans any transparent and well-laid out financial road map, detail mechanism of its operation, level of involvement and consensus reached with all the States on funding and implementation, specific timeframe for its rollout, besides addressing almost a collapsing public health-infrastructure framework in most States, the Government appears rather unprepared with HCP rollout in 2018.

Does this announcement for HCP, therefore, not reflect a bit of haste, if not an intent to achieve any other non-related objective? Thus, this edict didn’t fetch a WOW moment to me, at least for this year, or…did it?

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.

For Improving Drug Quality in India – A Bizarre Intent

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On January 16, 2017, quoting a Government source, a media report revealed, “India’s drug regulator is looking to inspect US pharmaceutical facilities, making critical medicines so that only high-quality products are imported from them.”

This intent follows a similar decision of the apex regulatory body – the Central Drugs Standard Control Organization (CDSCO), against some Chinese manufacturers on drug quality concern. The latest proposal to this effect was sent to the health ministry the previous week – the above report adds.

In this article, I shall explore the fundamental basis of this specific initiative. If it has any, I shall try to fathom whether it’s yet another case of misplaced priority of the decision makers, if not a bizarre one.

The current perspective:

About a couple of years ago, an article published in the global financial daily – the Financial Times, on September 9, 2015 titled, ‘Indian drugs: not what the doctor ordered’, articulated that the Indian pharma industry ‘now face a serious credibility crisis, as they battle to allay western regulators’ concerns about their manufacturing practices — especially the reliability of data from trials of their medicines.’

The report also pointed out: ‘Overseas regulators have been scrutinizing and banning products from some of India’s biggest and most reputable groups — including Sun Pharmaceuticals, IPCA, and Wockhardt – many of which have ongoing relationships with large multinational drug companies.’

Has anything changed now?

Nothing perceptibly seems to have changed in this area since then, to set our ‘own house in order’. Not even after witnessing a barrage of drug quality related ‘import bans’ by the US-FDA that involves Indian manufacturers of all sizes and scale. Instead, CDSCO turns its focus on setting-right ‘others’ manufacturing houses with its reportedly meagre manpower resources. Curiously, these initiatives include even those countries, which are globally acclaimed for having stringent regulatory frameworks well in place, such as the United States (US) and the European Union (EU).

Where a justifiable reason exists:

On Chinese API import by different countries, the article titled “Imports To Fuel India’s Active Pharmaceutical Ingredients’ Requirements,” published by Bloomberg | Quint on November 15, 2017 brings out a nice comparison. It says: ‘Among the top emerging and developing economies, India is a major importer of bulk drugs from China at 54 percent, followed by Indonesia at 24 percent, Brazil at 12 percent and South Africa at 8 percent.’ It also writes, in comparison, most of the developed markets of the world import in the range of just 2-3 percent from China.’

Going by this fact, Indian drug regulator’s inspection of some of the Chinese API plants is, by all means, understandable – mainly for two reasons. One, India is largely dependent on Chinese bulk drugs for formulations manufacturing and consumption in the country, besides exports. And the second, some incidents of compromised Chinese drug ingredients have already been reported. For example, citing quality issues, the Drug Controller General of India (DCGI) has recently, reportedly banned import of such questionable drug constituents from six major Chinese pharma companies. This is not a solitary instance. Similar incidents involving Chinese drugs were  reported in the past, as well.

An irony:

When international media agencies flash headlines, such as “U.S. and EU regulators urge Indian drug companies to step up standards,” Indian drug regulators decide to inspect overseas manufacturing plants, as well. Such a decision becomes intriguing, especially when it includes those countries, where from imports are meager, besides their stringent drug quality standards being globally acclaimed.

This is an irony, as the recent local media headlines like, “India among countries where 10% of drugs are substandard: WHO” or “… 27 medicines sold by top firms ‘fail’ quality tests in seven states”, unfold the veracity of drug regulatory laxity within the country.

The basis of the recent proposal becomes more incomprehensible, when the DCGI himself reportedly admits, even today that: “Substandard medicines are a major issue in India and we are looking out for ways to tackle the problem. As quality regulator, we are developing proper mechanisms to stop manufacturing and sale of counterfeit drugs so that they don’t reach the patients.”

The reasons cited for overseas plant inspection:

According to media reports, the reasons cited in the CDSCO proposal for Indian Drug Inspectors’ (DI) inspecting other overseas manufacturers, including those in the US and Europe, are broadly as follows:

  • Most of over 28 manufacturing sites registered in India from the US, manufacture critical formulations or critical new therapies, which are not available in other countries, as they fall into high-risk categories.
  • Inspections will not only result in compliance to the Drugs and Cosmetics Act and Rules, but also give exposure to Indian drugs inspectors to new technology adopted in the manufacturing and state-of-the-art facilities.
  • The sites will be inspected if they have made substandard drugs, received quality complaints, or faced action by other regulatory authorities.
  • Companies shortlisted for the proposed inspections include those making biologic and anti-cancer medicines.

Let me hasten to add, there is nothing wrong with this intent as such, but the moot point is: what’s the core issue that we are talking about? While addressing this point, let’s first have a quick look at India’s import of pharmaceutical product around the last two decades.

India’s import of pharmaceutical products – 1996 – 2018:

According to ‘Trading Economics’ (last updated in January of 2018), India’s import of pharmaceutical products decreased to USD 254.57 Million in 2016 from USD 795.34 Million in 2015. Average drug imports are shown as USD 645.06 USD Million from 1996 until 2016, reaching an all-time high of USD 1747.65 Million in 2012, and a record low of USD 64.32 Million in 1996.

Nonetheless, the micro- picture of India’s bulk drugs or API import isn’t quite the same. On December 19, 2017 in a written reply to the Lok Sabha, the Minister of State, Chemicals and Fertilizers gave details of India’s bulk drug imports from top five countries, as follows:

Country Import value Rs Crore Import value $ Million (Approx.)
China 12,254.97 1915 (66%)
United States 820.18 128 (4.5%)
Italy 701.85 110 (3.8%)
Germany 485.11 76 (2.6%)
Singapore 422.01 66 (2.3%)
Total 18,372.54 2871

It’s worth noting, although the overall value of API import has declined, including from China, its volume share still remains too high in India. More importantly, Indian drug import from the United States and the European countries, are not only very small, there doesn’t seem to be enough instances of substandard drugs imported from these countries to India, either.

The core issue:

Taking a serious note of the reported incidences of widespread substandard drugs by various reports, including the WHO, the core issue becomes rather obvious. What else could possibly be the core issue other than taking effective remedial regulatory measures to contain the menace of substandard drugs circulating within the country?

An article titled, “Correcting India’s Chronic Shortage of Drug Inspectors to Ensure the Production and Distribution of Safe, High-Quality of Medicines,” published by the International Journal of Health Policy and Management (IJHPM) on April 27, 2017, made an important observation in this regard.

It reiterated: Good drug regulation requires an effective system for monitoring and inspection of manufacturing and sales units. In India, despite widespread agreement on this principle, ongoing shortages of drug inspectors have been identified as a major hindrance to this effort by the national committees, since 1975. Rapid growth of India’s pharmaceutical industry and its large export market makes the problem more acute.

Thus, the major remedial measure that CDSCO needs to take on priority to effectively address this core issue, is the chronic shortage of competent drug inspectors in the country.

An assessment of the current situation:

On the ground, the above situation continues to prevail almost in every state of the country, with a varying degree, though. However, at this point, I shall quote just three such instances – only to illustrate the gravity of the situation.

Example 1 – Delhi:

The article titled, “Delhi’s pharmacy woes: Only 21 inspectors for city’s 25,000 chemists,” published by ‘India Today’ on November 25, 2017, well-captured the latest scenario in this regard, of India’s national capital – New Delhi.

It wrote, there’s no guarantee that the medicine you are buying from a pharmacy is safe. The drug regulatory body does not have enough manpower to conduct regular inspections of the city’s mushrooming chemist shops and wholesale units.

Against the sanctioned posts of 31 drug inspectors, the department has only 21 DI for keeping an eye on Delhi’s 25,000 medical stores, and blood banks. Quoting Government officials the report reiterated, while the number of DI has declined – or at best remained constant – over the past 40 years, the number of pharmacies has increased from 5,000 to 25,000.

Whereas, going by the Centre’s recommendation, Dr. Mashelkar Committee report and the Task Force Committee’s observation, there should be one drug inspector for every 50 manufacturing units. Considering the magnitude of the problem, the Drugs Technical Advisory Board (DTAB), in a recent meeting, reportedly suggested, there should be one official for every 200 sales outlets, and one official for every 50 manufacturing units.

Example 2 – Kerala:

Another report of July 08, 2017, with a similar headline – “Remedial action needed in medicine market”, focused on one more important state – Kerala. It wrote that the Kerala has just 47 drug inspectors to monitor the entire State drug market that has over 20,000 drug stores, excluding those located in the hospitals. “In Kerala – the consumer of about 15 to 20 percent of drugs manufactured in the country, there are no quality checks taking place owing to the manpower shortage” – the article cautioned.

Example 3 – Maharashtra:

Yet another national media report of March 16, 2017 carried a headline ‘FDA faces staff shortage again.’ It discussed the same issue for a major State where the financial capital of India is located – Maharashtra. Giving details, the article pointed out that out of 160 posts of drug inspectors across Maharashtra, only 90 have been filled so far and of the 250 food safety officer posts, just 180 have been filled. More than 50,000 pharmacies, 15,000 wholesalers and over 8,000 manufacturing units, are supposed to be properly governed as per the regulatory rules and godliness, to ensure high quality drug safety standards, by this meager DI staff strength of the State.

Conclusion:

Against the above backdrop, it appears absolutely minimum to expect that CDSCO would make the public know, how does it plan to make the drugs manufactured for domestic consumption of high quality standards, as a safeguard to patients’ health and safety.

This calls for strict quality audits by the DIs of the individual states, at pre-determined periodicity, just as what US-FDA does to ensure exactly the same, for patients in their own country. With dwindling resources of DI, CDSCO seems to be continually failing in achieving this critical goal. There doesn’t seem to be any specific and transparent accountability criteria in place, for the CDSCO to comply with.

In this situation, the plan to audit the overseas manufacturing plants located in the US and EU for drug quality assessment, carving out a slice from the existing DI manpower strength, appears rather foolhardy. Moreover, the safety-risk for those imported medicines is apparently low, not just due to meager quantity of drug import, but also for stringent regulatory environment prevailing in those countries.

In view of all this, the media report on CDSCO’s plan to inspect US and EU pharma facilities, making ‘critical’ drugs to ensure high product-quality, is interesting. If it holds any water, the initiative may be construed by many not merely a case of misplaced priority, but a bizarre one, to say the least.

By: Tapan J. Ray 

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

Health Care in India And ‘Development For All’ Intent

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‘Development for All’ has become a buzzword, especially in the political arena of India, and is being used frequently during all recent elections as no one can deny its crucial importance in a country like ours.

Nonetheless, some do feel that there should be greater clarity on what all it encompasses. There is no scope for assumption, either, that it definitely covers the economic growth of the nation. But, does it include health care for all, as well? This is a relevant question, since health care plays a crucial role in maintaining high growth of Gross Domestic Product (GDP) by any country, over a long period of time.

The ideal answer to this question would, of course, be an emphatic ‘yes’? However, on the ground is it really so? I explored that subject in my article published in this Blog on November 06, 2017 titled, ‘Healthcare in India And Hierarchy of Needs’.

In this article, I shall focus on health care and the ‘Development for All’ agenda of the Government, as witnessed by many in recent elections. Let me illustrate the point using one of the most recent state assembly elections as an example – Gujarat Assembly election of December 2017. I am citing this example, because it generated so much excitement among many, across the country, for different reasons, though.

Who is responsible for public health care in India?

A recent submission made on the floor of Parliament by the Government, explains the point unambiguously. It goes, as hereunder:

“Public health is a state subject. Under the National Health Mission, support is being provided to States/UTs to strengthen their health care systems to provide accessible, affordable and quality health care to all the citizens. Moving towards Universal Health Coverage wherein people are able to use quality health services that they need without suffering financial hardship is a key goal of 12th Plan.” This is what the Minister of State, Health and Family Welfare, reiterated in the Lok Sabha, just about a year ago, on November 25, 2016.

Since, public health is predominantly a state subject, and so important for each individual, besides being one of the key indicators for long-term socioeconomic progress of a country and, one expects health care to be a key issue during the state Assembly elections. This is necessary to maintain the pace of development in this area, be it a state or the country.

Intriguingly, it appears to have no more than a ‘me-too’ reference in the election manifestos of political parties.

Does health care scenario in a state matter?

Now, zeroing on to Gujarat election as an example, the media report of March, 2017 highlighted, gradually reducing budget allocation percentage of health care in Gujarat. It elaborated, the State has reduced its budgetary allocation for health care from 5.59 percent of the total budget in 2015-16 to 5.40 percent of the revised budget of 2016-17, and now to 5.06 percent in 2017-18.

Consequently, the health care budget and spending on the proportion to the Gross State Domestic Product (GSDP) is going down year after year. Whereas, globally, the percentage of GSDP spent on health and education is considered a key parameter of human development, the report states.

According to a report of the Observer Research Foundation dated December 06, 2017, Gujarat still has a high dependency to the private sector for both outpatient (84.9 percent cases) and also the inpatient (73.8 percent cases). As a result, the out of pocket spending on health care of the state stands at 63.7 percent. This makes Gujarat climbing up the ladder of per capita income, while slipping down the slope of health and social indicators,” the article states.

Just as what happens in all other Indian states, the recent state assembly elections offered an opportunity for the political leadership, cutting across the party line, for a significant course correction. Making health and nutrition one of the top priority focus areas, would have also ensured sustain economic development for Gujarat, in a more inclusive manner, for a long time to come.

What we are witnessing, instead:

The ‘best’ intent of a political party on any area of governance, if it comes to power, generally gets reflected in the respective election manifestos. From that perspective, let’s take a quick look at the key promises on health care, made in the respective election manifestos of the two principal political parties, on the eve of December 2017Gujarat election. I found these, as follows:

Key highlights on health care in BJP Manifesto:

  • The party promised to open more generic medicine shops
  • Introduce mobile clinics and laboratories
  • Making Gujarat free of vector-borne diseases.

Key highlights on health care in Congress Manifesto:

  • Universal health care card

That’s all?… Yes, that’s it.

India is ‘developing’, but public health care is not:

‘The Lancet’ editorial titled, ‘Health in India, 2017’, published on January 14, 2017, discussed about the current status of public health care in India. It underscored that the government expenditure on health being one of the lowest in the world at 1·4 percent of GDP, is totally inadequate to train staff, buy necessary equipment, or efficiently run public health facilities.

Corruption and an unregulated private sector usually fill this vacuum, and in so doing, fuel irresponsible prescribing, and global export of antimicrobial resistance, besides misery and medical bankruptcy for those within the country, lacking financial protection.

The editor articulated that the solution of this important issue is clear. Publicly financed Universal Health Coverage (UHC) has not only been deliberated in India since the dawn of the nation, but has also been highly recommended by both the domestic and the external stakeholders.

Nevertheless, successive governments seem to be lacking either the spine or the heart to act. As recently as 2011, progressive universalism was included in the government’s 5-year plan, but was never funded – the editorial commented.

Both the States, and also the national election campaigns, offer an opportunity for the politicians who the prospective lawmakers, to steer the States, and in that process the country as a whole, moving towards the UHC.

Conclusion:

As heath is a state subject, the issue of providing access to high quality and affordable health care to all should ideally become one of the core issues for all voters, at least, in the State Assembly elections. More so when the sound bite on ‘development for all’ reaches a feverish pitch. There can’t be any holistic ‘development for all’, sans health care and education.

Nonetheless, the reality is, unlike the United States, Europe or Japan, besides a few other countries, the voters in India are also not expressing their concerns in this area, meaningfully. In all probability, ‘development for all’ slogan of the politicians doesn’t include health care to all Indians.

This is likely to continue, in the same way, till the awareness of the socioeconomic impact on health care carves out a niche for itself in the popular political agenda for the voters. Just as what happens with many other economic, technological necessities and other aspirations of people. The recent assembly elections are important pointers to this long persisting trend.

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.

Leveraging Artificial Intelligence For Greater Patient-Centricity

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‘Artificial Intelligence (AI)’ – the science of simulation of intelligent behavior in computers, has the potential to leave a transformational impact on virtually everything that we see and feel around us. As many will know, the modern definition of AI is “the study and design of intelligent agents where an intelligent agent is a system that perceives its environment and takes actions which maximizes its chances of success.”

Let me begin with a couple of exciting examples on the application of AI for general use. One such is Siri the voice-activated computer in the iPhone that one can interact with as a personal assistant, every day. The other is the self-driving features with the predictive capabilities of Tesla cars; or even the well-hyped Google driver-less car. Alongside, Google is also in pursuit of creating AI with ‘imagination’ through its ‘DeepMind’. It develops algorithms that simulate the human ability to construct plans.

Pharma’s emergence in the AI space:

The unfathomable potential of AI is being slowly recognized in the healthcare arena, as well, including pharma industry. It’s gradual emergence in the space of ‘intelligent learning’, often called ‘machine learning’, ushers in a new paradigm of learning from a vast pool of highly credible real-time data. Innovative applications of this process can fetch a game changing business performance. Its scope spans right across the pharma value chain – from Drug Discovery, including Precision Medicine; Clinical Trials; Pharmacovigilance; Supply Chain Management, and right up-to Sales and Marketing.

Pharma’s emergence in the AI space is quite evident from Reuters report of July 3, 2017. It wrote that GlaxoSmithKline (GSK) has inked a new USD 43 million deal with Exscientia to help streamline the company’s drug discovery process by leveraging AI. With this deal in place, Exscientia will allow GSK to search for drug candidates for up to 10 disease-related targets. GSK will provide research funding and make this payment, if pre-clinical milestones are met.

Again, on July 27, 2017, Insilico Medicine – a Baltimore-based leader in AI, focusing on drug discovery and biomarker development, announced a similar agreement with the biotechnology player Juvenescence AI Limited. According to this agreement, Juvenescence AI will develop the first compounds generated by Insilico’s AI techniques, such as Generative Adversarial Networks in order to generate novel compounds with desired pharmacokinetic and pharmacodynamic properties.

Several other pharmaceutical giants, including Merck & Co, Johnson & Johnson and Sanofi are also exploring the potential of AI for streamlining the drug discovery process. It would help them to significantly improving upon the hit-and-miss business of finding new medicines, as Reuters highlighted.  Eventually, these applications of AI may be placed right at the front-line of pharma business – in search of new drugs.

I have already discussed in this blog – the ‘Relevance of AI in creative pharma marketing’ on October 31, 2016. In this article, I shall mainly focus on leveraging AI in health care for greater patient-centricity, which is emerging as one of the prime requirements for excellence in the pharma business.

Imbibing patient-centricity is no longer an option:

In an article published in this blog on the above subject, I wrote that: ‘providing adequate knowledge, skills and related services to people effectively, making them understand various disease management and alternative treatment measures, thereby facilitating them to be an integral part of their health care related interventions, for better health outcomes, are no longer options for pharma companies.’

The craft of being ‘patient-centric’, therefore, assumes the importance of a cutting-edge  of pharma business for sustainable performance.

What exactly is ‘patient-centricity’?

BMJ Innovations – a peer reviewed online journal, in an article titled, ‘Defining patient centricity with patients for patients and caregivers: a collaborative endeavor’, published on March 24, 2017, defines ‘patient-centricity’ as: “Putting the patient first in an open and sustained engagement of patient to respectfully and compassionately achieve the best experience and outcome for that person and their family.”

Thus, to deliver the best experience, and treatment outcomes to patients, their participation and engagement, especially with the doctors, hospitals and the drug companies assume significant importance.

The June 2017 ‘Discussion Paper’ of McKinsey Global Institute, titled ‘Artificial Intelligence the Next Digital Frontier’ also captured this emerging scenario, succinctly. Recognizing that health care is a promising market for AI, the paper highlighted the enormous potential in its ability. The power of which can draw inferences by recognizing patterns in large volumes of patient histories, medical images, epidemiological statistics, and other data.

Thus, AI has the potential to help doctors improve their diagnoses, forecast the spread of diseases, and customize treatments. Combined with health care digitization, AI can also allow providers to monitor or diagnose patients remotely, as well as transform the way we treat the chronic diseases that account for a large share of health care budgets, the paper underscored. This poses the obvious question: what exactly AI can possibly do in the space of health care?

What can AI do for health care?

In a nutshell, the application of AI or ‘machine learning’ system in health care generally uses algorithms and software to approximate human cognition in the analysis of relevant, yet complex scientific and medical data. In-depth study and interpretation of these in a holistic way would be of immense use in many areas. For example, to understand the relationships between prevention or treatment processes and outcomes, or various debilitating conditions affecting people with the advancement of age, to name just a few.

This necessitates the generation of a huge pool of relevant and credible data from multiple sources, storing and analyzing them meaningfully, and then garnering the capabilities of ‘machine learning’ with the application of AI. Such a process helps in zeroing-in to a series of complex, interdependent strategic actions to go for the gold, in terms of business results. Using conventional methods, as exist today, other than imbibing AI or ‘machine learning’, may indeed be a Herculean task, as it were, to achieve the same.

Invaluable business insights thus acquired need to be shared, across the various different functions of a company, for greater patient-centricity within the organization.

Moving from ‘patient-engagement’ to ‘patient-centricity’:

While making a significant move from just ‘patient engagement’ to being ‘patient centric’, one-size-fits-all strategy is unlikely to yield the desired results. The process of gathering adequate knowledge and understanding of any individual’s disease management skills, which mostly depend on complex multi-factorial, interrelated and combinatorial algorithms, will be a challenging task, otherwise.

Thereafter, comes the need to deliver such knowledge-based value offerings to target patients for better health outcomes, which won’t be easy, either, in the prevailing environment.

Considering these, AI seems to have an immense potential in this area. Some global pharma players are also realizing it. For example, GSK is reportedly engaged with IBM’s Watson in the development of AI-enabled interactive digital Apps for its cold and flu medication to provide relevant information to patients.

Conclusion:

Patient-centricity would soon be the name of the game for pharma business excellence. However, to be truly patient-centric, especially in the sales and marketing operations, pharma players would require to source, process and analyze a huge volume of relevant data in several important areas. These include, target patients, target doctors, environmental dynamics, demographic variations, regulatory requirements, current practices, competitive activities, to name a few.

In this strategic business process, AI or ‘machine learning’ will help accurately mapping the ongoing dynamics and trends in virtually all critical areas. It will help ferret out the nuances of turning around the competitive tide, if any, and that too with immaculate precision. In that sense, AI is likely to emerge as a game changer in imbibing patient-centricity, in the real sense. Consequently, it carries a promise of delivering significantly better outcomes, yielding higher financial returns, alongside.

Although, some concerns on AI are being expressed by several eminent experts, it is generally believed that on the balance of probability, it’s crucial potential benefits far outweigh the anticipated risks. In my view, this holds good even for the pharma industry, especially while leveraging AI for greater patient-centricity, better disease prevention, and more desirable treatment outcomes – improving the quality of life of many, significantly.

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.

 

A Tipping Point For Robust Healthcare System In India

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“Given the popular uptake of universal health coverage reforms elsewhere in Asia, the Feb 4 elections may be a tipping point for health in India. For example, in 2012, Joko Widodo was elected Governor of Jakarta. He launched popular UHC reforms in the capital and 2 years later was elected president. In 2016, voters in the USA and UK supported politicians prepared to act on the concerns of the electorate. If health becomes a populist cause in India, rather than a political inconvenience, then the country might finally be liberated to achieve health outcomes commensurate with its economic and technical achievements”, is exactly what appeared in the editorial of The Lancet, titled “Health in India, 2017,” published on January 14, 2017.

The Lancet Editor further reiterated: “Because states have responsibility for health, the elections will raise the importance of access to quality, affordable health care in India, regardless of the electoral outcome. It is a debate that needs to be fostered.”

This is, of course, a ‘top-down’ approach for healthcare, as seen in several countries across the world. However, I have recently deliberated another approach in the same area on – why a ‘bottom-up’ demand is not forthcoming in India, in an article titled ‘Healthcare in India And Hierarchy of Needs’, published in this blog on November 06, 2017.

No one, including any Government, would possibly ever argue – why shouldn’t a robust public healthcare system in a country, including the availability of reasonably affordable drugs, assume as much priority as economic growth and education?

On the contrary, Governments in several other countries, including those with a well-functioning Universal Healthcare (UHC) in place, are trying to ensure even better and greater access to healthcare for all, by various different means. In this article, I shall focus on it, in a holistic way.

Exploring a bottom-up approach:

It is increasingly becoming more evident that a bottom-up approach would help yield greater success in this area, with a win-win outcome. It will involve taking the stakeholders on board in the process of framing and implementing healthcare projects within a given time-frame. The question then arises, why is it still not happening on the ground in India the way it should? Just floating a discussion paper on draft projects and policies, for stakeholders’ inputs, isn’t enough any longer. There is a need to move much beyond that in making these decisions more inclusive.

Various successive Governments may have some justifiable funding related or other pressing issues to offer a robust public healthcare system in India. But, none of these will be an insurmountable barrier, if more number of heads of astute stakeholders are involved in ferreting out an effective and implementable India-specific solution in this area, within a pre-determined timeline.

There are examples of remarkable progress in this direction, by involving stakeholders in charting out a workable pathway, agreed by all, and jointly implemented in a well-calibrated and time bound manner. Equally important is to make this plan known to the public, so that the Government can be held accountable, if it falls short of this promise, or even misses any prescribed timeline.

‘The Accelerated Access Pathway’ initiative:

Let me now draw an interesting example of involving stakeholders by the Government to improve patient access to expensive and innovative drugs. This example comes from a country that is running one of the oldest and most efficient UHC in the world – the United Kingdom.

Despite a robust UHC being in place, the National Health Service (NHS) in England had a perennial problem to make ‘breakthrough’ medicines available early to NHS patients. The British pharma industry reportedly had a long-held complaint that patients in England get a raw deal when it comes to accessing the latest medicines.

According to a reported study by the Association of the British Pharmaceutical Industry (ABPI) and endorsed by the charity Cancer Research UK, average British patients get lower access to leading cancer medicines than their European counterparts.

To resolve this issue effectively, the British Government launched ‘The Accelerated Access Pathway initiative’. Former GSK global CEO Sir Andrew Witty was named as the chairman of this collaborative body. The scheme, launching from April 2018, will see approvals of cutting-edge treatments for conditions like cancer, dementia and diabetes dramatically speeding up. The pathway is expected to get ‘breakthrough’ medicines to NHS patients up to four years earlier, as the report, published in ‘The Telegraph’ on November 3, 2017 indicates.

It is believed that ‘Accelerated Access Collaborative’ initiative would benefit the NHS patients, as well as deliver significant long-term savings for the health service.

Similar initiatives may be effective in India:

Taking collaborative initiatives, such as above, may not be absolutely new in India. However, in a real sense, Indian initiatives are no more than top-down approaches, and not in any way be termed as bottom-up. Moreover, these usually originate in the form of Government discussion papers inviting comments from the stakeholders.

Moreover, in the healthcare policy related arena, there is no subsequent firm resolve by the Government to chart out a clear pathway for its effective implementation, with specific timelines indicated for each step, besides assigning individual accountability for delivering the intended deliverables.

Any such decisive move by the government, keeping all stakeholders engaged is quite rare to come across in our country, as yet. Thus, carefully selected outside expert group suggestions based – the National Health Policies also have met with the same fate, without possibly any exception, thus far.

Two illustrations:

I shall illustrate the above point with two top-of-mind examples. The first one is a report – the ‘High Level Expert Group (HLEG)’ report on ‘Universal Health Coverage (UHC)’ for India, submitted to the erstwhile Planning Commission in November 2011. The other example is of a policy – the National Health Policy (NHP) 2017, which is in place now, based on a report by an expert committee constituted by the Government.

Let me now briefly recapitulate both – one by one, as follows:

The report on ‘Universal Health Coverage (UHC)’ for India

The ‘High Level Expert Group (HLEG)’ on ‘Universal Health Coverage (UHC)’ was constituted by the Planning Commission of India in October 2010, with the mandate of developing a framework for providing easily accessible and affordable health care to all Indians.

While financial protection for healthcare was the principal objective of this initiative, it was recognized that the delivery of UHC also requires the availability of adequate health infrastructure, skilled health workforce, access to affordable drugs and technologies to ensure the entitled level and quality of healthcare is delivered to every citizen.

The report further highlighted, the design and delivery of health programs and services call for efficient management systems as well as active engagement of empowered communities.

The original terms of reference directed the HLEG to address all of these needs of UHC. Since the social determinants of health have a profound influence not only on the health of populations, but also on the ability of individuals to access healthcare, the HLEG decided to include a clear reference to them.

Nevertheless, this report was never acted upon for its effective implementation. Now, with the change in Government, HLEG recommendations for UHC in India seems to have lost its relevance, altogether.

The National Health Policy (NHP) 2017

The new Government that subsequently came to power, decided to start afresh with a brand new and modern National Health Policy in India, replacing the previous one framed 15 years ago in 2002. NHP 2017 promises healthcare in an ‘assured manner’ to all, by addressing the challenges in the changing socioeconomic, epidemiological and technological scenarios. Accordingly, the National Health Policy 2017 was put in place, early this year.

To achieve the objectives, NHP 2017 intends to raise public healthcare expenditure to 2.5 percent of GDP from the current 1.4 percent. Interestingly, no visible signal about the seriousness on implementation of this laudable initiative has reached the public, just yet.

Let’s now wait for the next year’s budget to ascertain whether the policy objective of ‘healthcare in an assured manner to all’ would continue to remain a pipe dream, as happened in earlier budget proposals. It is noteworthy that union budget allocation on health did not go up, at least, in the last 3 years, despite categorical assurances by the ministers on increasing focus on healthcare.

Significant increase in both the union and the state governments budgetary allocation for healthcare is necessary. This is because, besides many other intents, NHP 2017 intends to provide free diagnostics, free drugs and free emergency and essential healthcare services in all public hospitals for healthcare access and financial protection to all.

Universal Healthcare is the core point in both:

The core focus of both – the HLEG report and also the NHP 2017, is UHC in India, but with different approaches. When HLEG report was not translated into reality, the 2014 general election in India was widely expected to be the tipping point for a new public healthcare landscape in the country fulfilling this promise. More so, as the public healthcare system is generally in a shamble throughout the country, except in a handful of states.

Just as in the United States, Europe or Japan, “if health becomes a populist cause in India, rather than a political inconvenience, then the country might finally be liberated to achieve health outcomes commensurate with its economic and technical achievements,” as the above Lancet editorial commented.  Giving yet another perspective, I also wrote in my blog post, titled ‘Healthcare in India And Hierarchy of Needs’ on November 06, 2017, why has it not happened in India, as on date.

Conclusion:

What happens, if the Indian Government too adopts a major collaborative approach, such as ‘The Accelerated Access Pathway’ initiatives, involving all stakeholders – including the pharma and device industry leaders to implement UHC in the country – part by part?

The relevant counter question to this should not be – Will that work? Of course, it will, if the Government wants to. On the contrary, it could be a potential ‘Tipping Point’ to create a robust public healthcare landscape in India. Thus, the real question that we should ask ourselves: Why won’t it work, when all stakeholders are on board to pave the pathway for an efficient Universal Healthcare system in India, in a win-win way?

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.

Drug Price Control And National Health Security

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‘Without Providing Affordable Medicines, There Can’t be Health Security’, said the Union Minister of Chemicals and Fertilizers of India, as reported on September 22, 2017. Although, the Minister made this remark while discussing Government price control on cardiac stents in India, let me dwell on the subject based on the above news headline by asking: Is drug price control improving access to medicines for greater ‘Health Security’ of the country?

It’s no rocket science to understand that making affordable drugs ‘available’ in requisite quantity for all, is essential, basically, for improving ‘access’ to medicines. Nevertheless, the mere availability of drugs is no guarantee for their improving access to all.

If we take a closer look at the well-articulated key objectives of the Ministry of Chemicals and Fertilizers, under which both the Department of Pharmaceutical (DoP) and the National Pharmaceutical Pricing Authority (NPPA) belong, this dichotomy will be easier to fathom.

The key objective of the ‘National Pharmaceutical Pricing Policy: 2012’, which is operational today, reads as: “To put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines – “essential medicines” – at reasonable prices even while providing sufficient opportunity for innovation and competition to support the growth of the industry, thereby meeting the goals of employment and shared economic well-being for all. The reasons are further elaborated later in the Policy Document.”

Similarly, according to the NPPA, one of the key objectives of drug price control in India is to ensure abundant availability, at reasonable prices of essential and life-saving and prophylactic medicines of good quality. Hence, the current key focus of the DoP and NPPA, on paper, does not go beyond making ‘affordable drugs available for all.”

Thus, the crucial point to ponder: Is ongoing drug price control, improving even availability of medicines for all to attain greater ‘health security’ of the country, as the Union Minister underscores?

A course correction without flagging the new course:

The Draft Pharma Policy 2017 makes an important course correction to address this critical issue. It expresses its objective in this important area slightly differently, by adding the word ‘accessible’, as: “Making essential drugs ‘accessible’ at ‘affordable prices’ to the common masses.”

Intriguingly, the draft remains mute, when it boils down to answering the fundamental question, how would this new policy improve access to affordable drugs for the common masses, without having any jurisdiction to improving access to overall health care? That turf, unquestionably, belongs to the Ministry of Health. Thus, I reckon, achieving this modified goal, in its totality, is no more than a rhetoric.

Would better availability guarantee greater patient access to drugs?

As things stand today, it is quite unlikely to happen. The broad process of improving access to health care in a holistic way, is enshrined in the  National Health Policy 2017, which is already in place. It assures the nation of progressively achieving ‘Universal Health Coverage (UHC)’. It outlines measures to improve the availability, access and affordability for quality secondary and tertiary care services, with significant reduction in ‘out of pocket expenditure’ on health care. The policy also emphasizes that this process would considerably reduce the proportion of households experiencing catastrophic health expenditures, and consequent impoverishment.

The silo mentality won’t work:

Although, the Ministry of Health is primarily responsible for meeting universal access to health care, which includes drugs, the Ministry of Chemicals and Fertilizers too, shoulders a crucial responsibility in this area. Thus, attaining the Health and Pharma policy goals – individually, collectively and meaningfully, both these Ministries need to work closely together, along with the State Governments, in the true spirit of cooperative federalism. The silo mentality has not worked and won’t work, ever, to meet health aspirations of the people.

Access to health care – a prerequisite to improving access to affordable drugs:

As I see it, access to health care for all is a prerequisite to improving access to affordable drugs for country’s ‘health security’. Without providing access to requisite health care, making affordable drugs available for all, does not make much sense, if at all. This is because, patients will buy or get medicines only when a medical or paramedical professional will advise and prescribe them what to buy while treating any particular ailment.

Is the key pharma policy goal anywhere near its target?

Be that as it may, let me now try to gauge whether even the current key goal of the pharma policy to make an increasing quantity of affordable drugs available to more number of the population is anywhere near its target or not.

Capturing the impact of the present pharma policy on the ‘health’ of Indian pharma industry, the Annual Report 2016-17 of the Department of Pharmaceuticals (DoP) acknowledges that owing to the Government’s efforts to make medicines affordable, the domestic Pharma market witnessed a slowdown in the ongoing financial year. The industry registered a decline in growth of 7.4 percent over the corresponding figure for 2014 -15, with a similar aftermath in its financial performance.

Interestingly, a Press Release of Ministry of Chemicals and Fertilizers of September 27, 2016 claims that ‘ceiling prices’ of 464 formulations fixed after announcement of NLEM, 2015 and Revised Schedule-I, resulted in savings of Rs 2288 crore for consumers. Let me also add that a September 22, 2017 tweet of the same Union Minister gives a much higher number in this regard, which includes cardiac stents, though.

Fair enough, in that increasing patient access to affordable drugs ought to get reflected in the reasonable incremental volume growth of the Indian Pharmaceutical Market (IPM), at least, of those products, which feature in the National List of Essential Medicines (NLEM)? Contrary to this expectation, according to an article published by ‘Pharmabiz’ website on the CPhI India Special supplement in December 2016, ‘over the past 3 years (FY 2013 – FY 2016), the IPM has grown at a CAGR of ~ 11%, much lower than its historical average growth rate of 15%.’

Thus, both the private retail audit data, and also the submission of the DoP clearly indicate that this has not happened, as a desired outcome of drug price control.

Drug price regulations aren’t irrelevant either:

My above argument doesn’t also mean that drug price control, or stringent price monitoring, or tough price negotiation – in whatever way one may call it, is of no use; even where Universal Health Care (UHC) is up and running. This is regardless of whether this universal care is insurance driven, as in the United States, or state funded, as in the United Kingdom. As I said before, access to health care for all is a prerequisite to improving access to affordable drugs. I stressed this point briefly in one of my recent articles published in this blog, while focusing on another important development.

Drug price regulation in the UHC countries:

In case of insurance driven UHC, insurance companies or related payers, or even the regulators, mostly enforce stringent control on drug prices, as is currently happening in the United States. This fact is vindicated by a May 29, 2017 report that indicates: “The pharma industry, under the constant glare of the US drug regulator, has to contend now with pricing pressures in the American market.” The report further highlighted: “From Sun Pharma and Lupin to Glenmark, Dr. Reddy’s and the others, price erosion in generic drugs has been a common anguish as they declared their results for the fourth quarter ended March 31. For some of these companies, more than 40 per cent of their revenues come from the US market. The developments came at a time new launches in the US – at least for some of them – have taken a hit because of regulatory action. Pricing pressure in generics is not new, but this has exacerbated in recent times, with experts warning of further deterioration.”

Similarly, where the UHC is funded by the State, such as in the United Kingdom, prices of branded pharmaceuticals supplied to the National Health Service (NHS), are controlled either by the ‘Pharmaceutical Price Regulation Scheme (PPRS)’ or by the ‘Health Service Branded Medicines Regulations 2008’. The situation is no different virtually in the entire Europe.

Moreover, in Japan, where UHC functions so immaculately, the regulatory officials of the country announced in December, as reported on 7th March 2017, the Government plans to review drug prices more frequently –  annually for all therapies and quarterly for the newest, and most expensive ones that are used widely. Over recent months, the price of Opdivo, a blockbuster cancer drug from Bristol-Myers Squibb Co. and Japan’s Ono Pharmaceutical Co., was halved in Japan following a 32 percent cut in April for Gilead Sciences Inc.’s hepatitis cure Sovaldi, the report said.

In addition, an OECD report dated January 16, 2017 observes: “The proliferation of high-cost medicines and rising drug prices are increasing pressures on public health spending and calling into question the pharmaceutical industry’s pricing strategies. Governments need to work with the industry and regulators to define a new approach to the development and use of new health technologies that encourages innovation while also delivering more affordable and value for money treatments.”

Hence, drug price regulations aren’t irrelevant, either in India or even in countries with a robust UHC system in place, not just yet.

The rationale behind drug price control in UHC countries and India:

The major difference in the rationale of drug price control between the countries with UHC and others, such as India is as follows:

  • UHC countries extend health coverage between 80 to 100 percent of the population, on an average, with a very low percentage of ‘out of pocket expenses’ on drugs. Hence, the Government and other payers want to keep their own cost of drugs within a reasonable limit with drug price control, though its methodology varies from country to country.
  • On the other hand, in countries, such as India, where UHC is not available, over 70 percent of the population incur ‘out of pocket’ expenses on health care – and over 60 percent of which is spent on drugs. Hence, the Government intends to ensure a significant reduction in ‘out of pocket expenditure’ towards medicines, by trying to make more affordable drugs available to many through drug price control.

Conclusion:

All health care related policy measures of the Government are important for the nation. As I know, the related discussion papers are circulated by the Government only after several informal and ongoing discussions on the subject with the stakeholders, and considering other feedbacks received in that process.

Despite this general mechanism, several points of draft proposals, or even the final policy, are often not liked by all, triggering a raging debate and inviting stringent criticisms, including disagreement from other ministries. For example, according to reports: “Even as Prime Minister Narendra Modi announced the government’s intention to ensure access to affordable medicines, the government policy think tank NITI Aayog seems to be pushing for greater deregulation of drug prices and to disempower India’s drug price regulator.” Just as many others, I also often participate in such debates.

That said, improving not just availability, but in tandem with greater access to affordable drugs, would play a key role to foster overall ‘Health Security’ of the country. Drug price control or its equivalent measures, alone, does not improve access to affordable drugs, except shaving off significant revenue and profit of the pharma companies. Whether the appropriate terminology in this case would be ‘profit’ or ‘profiteering’, is part of a separate debate, altogether.

Neither, impeccable sets of pharma and health policies, implemented in-silo by the two different ministries, will help achieve this goal. As is well researched, an excellent policy with shoddy or improper implementation, fetches far worse outcome than an average policy when implemented well, and in close coordination with other policies having common goals. This holds good even while striving for a robust ‘Health Security’ for the country.

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

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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.