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Covid 2.0 Rampages India As Top Echelon Policy Makers Ignore Science

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‘India is in the endgame of COVID,’ announced the union health minister of India, just in the last month – March 08, 2021. Although, it was then clearly known to medical fraternity that today’s Covid vaccines won’t be magic bullets against rapidly mutating new Coronavirus. Interestingly, a scientific-data based MIT study, published last year – on July 01, 2020 predicted that India might record the highest ever in the world – 287,000 new Coronavirus cases per day, by February 2021. At that juncture also Covid vaccines were expected to be available in India before that predicted time frame. The MIT study warning received a wide coverage even in India - by almost all news dailies, on that very month of the last year. The national Covid management team did not seem to have taken it seriously, along with others. These include, besides the top echelon of governance – a vast majority of Indians – across the social, political, religious and economic strata.

The fallout of such callousness – both at the individual Covid-appropriate behavior level, as well as Covid governance level, have been more disastrous than what was forecasted even in the above MIT study. The ferocity and scale of the second Covid-19 wave in India did not just overwhelm the nation, but raised grave concern across the world too. On April 22, 2021, India recorded the world’s biggest ever single-day rise with 314,835 new cases of Covid-19, causing death to 2,104 people. The very next day, this number increased to 332,730 new cases with 2263 deaths.

But, the peak of the Covid second wave hasn’t come, just yet. According to a mathematical model developed by a team of scientists from the IIT Kanpur and reported by news media on April 22, 2021, the number of active covid-19 cases in India during the second wave is expected to peak in May. The daily infection count is expected to exceed 350,000 cases. In this article, I shall dwell on three specific areas – acknowledging that the current scenario is the outcome of national misjudgment, if not a humongous misgovernance to prepare India for Covid 2.0:

  • Current struggle of India’s fragile and long-ignored health care infrastructure.
  • Need to neutralize some general misgivings on Covid vaccines and associated dilemmas.
  • Who is equipped to save people, if no external remedial measures remain unavailable for some more time?

India’s fragile and long-ignored health infrastructure can’t take anymore:

Amid this calamity, India has run short of oxygen, hospital beds, important Covid medicines, including Remdesivir. Curiously, reports keep coming incessantly confirm and reconfirm: ‘Ever since the second wave of the pandemic started, the healthcare systems in India have been teetering on the brink, with many hospitals unable to handle the relentless inflow of patients whilst also running short of beds, oxygen cylinders and other essentials.’

Doctors and many health care workers are overwhelmed by the massive scale of the human tragedy and in tears, as they articulate: ‘Many lives could have been saved had there been enough beds, oxygen supplies, ventilators and other resources – if the healthcare system had been better prepared for the second wave.’

The Supreme Court intervened, noting the ‘grim situation’ in the country:

Meanwhile, the Supreme Court of India, reportedly, ‘Suo motu’ (on its own) took note of the grim situation in the country and the havoc caused due to shortage of Oxygen cylinders in hospitals. Consequently, on April 22, 2021, the top court said, ‘it expected the Centre to come out with a “national plan” on the supply of oxygen and essential drugs for treatment of infected patients and method and manner of vaccination against the disease.’  The Delhi High Court also observed, “We all know that this country is being run by God,” coming down heavily on the Centre over the Covid-19 management.

Some Covid vaccine related misgivings and dilemmas:

Many people are raising questions of the efficacy of two currently available Covid vaccines in India – Covishield and Covaxin, especially against our probably ‘desi’ double mutant variety of Covid-19. The trepidation increased manifold when India’s former Prime Minister – Dr. Manmohan Singh got Covid infected after taking two doses of Covaxin. Or, reports, such as: ‘Sri Lanka reports six cases of blood clots in AstraZeneca vaccine recipients, 3 dead.’ Incidentally, these vaccines were made in India. Some may not possibly know that both the issues have been deliberated by the Indian scientists, who haven’t expressed any concern, as yet. This has to be shared with all by all concerned, soon. Let me explore some of these related issues, as follows:

Re-infection after taking Covid vaccines:

Regarding re-infection rate after taking two doses of Covid vaccines, the scientists have now released data establishing that only a very small fraction of those vaccinated with either Covaxin or Covishield, have tested positive. In any case, instances of a few “breakthrough” infections do not undermine the efficacy of the vaccines, they added.

The ICMR has also clarified, “These vaccines definitely protect against disease. However, the immune response begins to develop usually two weeks after every dose and there are variations within individuals, too. Even after the first dose, if exposure to the virus happens, one can test positive.”

Efficacy of Covishield and Covaxin against double mutant strains:

Notably, both – the Indian Council of Medical Research (ICMR) and the Centre for Cellular and Molecular Biology (CCMB) have announced last week that Covishield and Covaxin protect patients even from the ‘double mutant’, B.1.617, variety of Covid-19. Scientists believe that the “double mutant” is responsible for the sudden spike in the number of cases in Maharashtra and other parts of the country. They had earlier feared that this “double mutant” or B.1.617, may escape the immune system and thus vaccines may not offer protection from this strain of the novel coronavirus.

Reported risk of blood clotting with Oxford-AstraZeneca’s Covid-19 vaccine:

No cases of blood clotting have come to light in India. However, a government panel of experts is,reportedly, investigating for any domestic cases of blood clotting, even mild ones, as a side effect of the two COVID-19 vaccines being administered in India. According to India’s leading virologist Gagandeep Kang, “blood clots reportedly caused as a result of Oxford-AstraZeneca’s Covid-19 vaccine amount to a very small risk.”

As reported on April 24, 2021, the United States has also decided to immediately resume the use of Johnson & Johnson’s Covid-19 vaccine, ending a 10-day pause to investigate its link to extremely rare but potentially deadly blood clots. These details, I reckon, need also to be shared with all people, soon, in order to neutralize any doubt on administering Covid vaccines.

Covid vaccine availability and pricing:

Recent media reports highlight, at least six states of India – Andhra Pradesh, Chhattisgarh, Haryana, Maharashtra, Odisha and Telangana – are facing Covid vaccine shortage, as Covid 2.0 overwhelms India. Most of these states have already apprised the Centre of the situation, as the Supreme Court of India also seeks the details from the center about its current status.

As on April 22, 2021, India has administered over 135 million vaccine doses, where each individual will require two doses. Whereas, as published in Bloomberg on April 23, 2021, ‘1 billion Covid-19 vaccines have been administered around the world.’ The good news is, effective May 01, 2021, everyone above the age of 18 years will be eligible to get vaccinated. The Central Government will also lift its singular control on supply and delivery of Covid-19 vaccines in a bid to tackle the massive rise of cases that have crippled the country’s health infrastructure.

That said, the key question that follows – would Covid vaccine manufacturers be able to meet this increasing demand in India, when there already exists more demand than its supply? According to Niti Aayog Covid-19: Vaccine availability will improve by July 2021. The two major vaccine manufacturers in India are also indicating broadly similar time frame.

Meanwhile, amid a deadly second wave of Covid infections, a third Coronavirus vaccine - Russia’s Sputnik V, has been approved for emergency use in India. Incidentally, Sputnik V’s approval came not before India overtook Brazil to become the country with the second-highest number of cases globally. According to its local distributor – Dr. Reddy’s Laboratories, India will start receiving Russia’s Sputnik V vaccine by end May.

Be that as it may, it is still unclear whether enough Covid vaccine doses will be available right from May 1, 2021, to start inoculating all Indians above 18 years of age, across the length and breadth of the country. Besides, SSI’s decision to fix the rate of Covishield vaccine for private hospitals and state governments, has attracted sharp criticism from the Opposition, who argued that there was no logic in charging the state governments a higher price, when the Centre is getting the same vaccine at Rs 150 per dose.

This question surfaces, especially when SII Chief himself acknowledged that they are making profit even with Rs.150/per dose price as the pandemic ravages the nation. A news item of April 24, 2021 also underscores ‘Serum Institute’s Rs.600/dose for Covishield in private hospitals is its highest rate in the world.’ Nonetheless, price sensitivity to Covid vaccines during the pandemic is not specific to India.

Shareholders of Pfizer, J&J, reportedly, are also pushing for detailed COVID-19 pricing strategies of the respective companies, at their annual meetings. Curiously, at the same, yet another report highlights: ‘With the competition struggling, Pfizer’s COVID vaccine sales could hit $24B this year.’ Amazing!

India utterly overwhelmed, angry outbursts of concern beyond its shores:

Witnessing the nature of rampage caused by Covid 2.0 in India, global press blames the Indian top policy makers for utter failure to anticipate and tackle the devastating second wave. For example, The Guardian of the UK flashed a headline on April 21, 2021 – ‘The system has collapsed’: India’s descent into Covid hell.’ It further elaborated: ‘Many falsely believed that the country had defeated Covid. Now hospitals are running out of oxygen and bodies are stacking up in morgues.’ The Times, UK was harsher. It reported, ‘Modi flounders in India’s gigantic second wave.’ It further added: ‘Record levels of infection have put huge strain on the health service and highlighted the perils of complacency in the nationalist government.’

The New York Times reported on April 23, 2021: ‘India’s Health System Cracks Under the Strain as Coronavirus Cases Surge.’ The report also cited examples of ‘recent political rallies held by Mr. Modi that have drawn thousands, as well as the government’s decision to allow an enormous Hindu festival to continue despite signs that it has become a super spreader event.’

Conclusion:

Keeping aside the responsibility, or rather lack of it, of the National Covid governance team, individual Indians – like you and me – can’t in any way shy away from our own responsibility of compliance to Covid appropriate behavior, religiously. We are equally responsible, at least, for our own lives and fate. Even today, many of those who are wearing a face mask, are wearing in the chin – keeping the nose exposed – forget about double masking! Moreover, how many of us were or are eligible for Covid vaccination till date, but did not or could not take?

Curiously, Covid 2.0 is no longer striking mostly the poor urban population, living in slums or hutments, or the migrant laborer. Nor it is attacking mainly the senior citizens or people with co-morbidities. More young people, including children are getting infected in Covid 2.0. In Covid 2.0 – over 90 per cent of Covid new cases concentrate in in high rise and other buildings in major cities, like Mumbai. While urban slums account for just 10 per cent. On April 24, 2021, Bloomberg also reported, ‘India’s Urban Affluent Hit By New Virus Wave After Dodging First.’

Terming Covid 2.0 as concerning and scaring‘, Tata Sons Chairman also said, ‘India needs to get as many different Covid-19 vaccine licenses as possible. And replicate multiple factories on a war footing to ramp up production in order to meet the requirements as the country reels under the devastating second wave of the pandemic.’ It’s incredible, how a small country in the Indian subcontinent – Bhutan with limited resources, got its vaccination plan right and carried out, reportedly, the world’s fastest immunization drive.

Coming back to the last year’s above MIT study forecast for 2021 Covid situation in India. It goes without saying that this one, among several others, was based on credible data. It also brought to the fore the scientific reasons of consequences for not following the norms of Covid appropriate behavior. Looking back and coming back to real life scenario of date, one thing becomes crystal clear. When science is ignored, both at the highest echelon of national governance where the buck stops – or at the individual, social, religious or political level – it is virtually inevitable that a disaster would strike. And in most cases, it will strike hard – very hard. Much beyond what a human can withstand to survive. We have choice for survival – even in today’s frightening scenario. Let’s individually and collectively behave, as the science demands. Life and livelihood are important – for all of us.

By: Tapan J. Ray    

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

 

 

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

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

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

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

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

Ongoing economic cost of significant loss in productive years:

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

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

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

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

Pump-priming public health investments:

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

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

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

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

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

Help propel GDP growth:

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

Three key areas of healthcare:

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

  • Prevention
  • Diagnosis
  • Treatment 

Leveraging digital technology:

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

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

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

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

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

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

Disease treatment with medicines:

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

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

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

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

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

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

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

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

Conclusion:

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

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

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

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

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

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

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

By: Tapan J. Ray

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

Government Ups the Ante for More Compulsory Licenses in India

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On January 12, 2013, one of the leading dailies of India first reported that in a move that is intended to benefit thousands of cancer patients, Indian Government has started the process of issuing Compulsory Licenses (CL) for three commonly used anti-cancer drugs:

-       Trastuzumab (or Herceptin, used for breast cancer),

-       Ixabepilone (used for chemotherapy)

-       Dasatinib (used to treat leukemia).

For a month’s treatment drugs like, Trastuzumab, Ixabepilone and Dasatinib reportedly cost on an average of US$ 3,000 – 4,500 or Rs 1.64 – 2.45 lakh for each patient in India.

CL through a different route:

This time the government can reportedly notify its intent to grant  CL under Section 92 of the Indian Patents Act 2005, only if any of the following three conditions are met:

- National emergency

- Cases of extreme urgency

- Public non-commercial use

After such Government notification in the gazette, any company interested in manufacturing any or all of these three products can directly apply for a CL to the Indian Patent Office (IPO).

This route is also expected to save usual litigation costs for the interested pharmaceutical players.

In such case, this will be the first time in India, when instead of pharmaceutical players applying for CL the Government on its own will trigger the CL process.

A situation like this will undoubtedly signal immense unpredictability in the IPR environment of the country.

Incongruent with the New Drug Policy 2012:

Interestingly, section 4(xv) of the National Pharmaceutical Pricing Policy 2012 (NPPP 2012) under ‘Patented Drugs’ states as follows:

“There is a separate Committee constituted by the Government order dated 1st February, 2007 for finalizing the pricing of Patented Drugs, and decisions on pricing of patented drugs would be taken based on the recommendations of the Committee.”

A media report also highlighted that an inter-ministerial group constituted for regulating prices of patented medicines in India has recommended using a per capita income-linked reference pricing mechanism for such products.

Thus, it is rather intriguing for many to fathom, why is the Government contemplating to grant CL on the above three anti-cancer drugs in January 2013, despite the decision of the Union Cabinet on the same in the new Drug Policy as recent as December, 2012.

Medicines come at the third stage of a medical treatment process:

For all patients, including the cancer victims, medicines will come at the earliest in the third stage of any treatment process, the first two or in some cases first three stages being:

  • A doctor’s intervention
  • Correct diagnosis through diagnostic processes
  • Surgical interventions (in some cases)

In India, there is no regulation to address the ‘cost issues’ of the first two or three stages of treatment, though there is a dire need to facilitate the entire process and not just one. Coming straight to cancer medicines considering these as the only ‘magic wands’ to improve access to treatment, may well be considered as ‘jumping the gun’ by the Government, if not an imprudent decision.

Skewed healthcare distribution in India:

Healthcare distribution in India is rather skewed and cancer treatment is no exception mainly because of the following reasons:

  • Medical personnel are concentrated in urban areas.
  • 74 percent of doctors work in urban settlements, which is just around 1/4th of the population.
  • 61 percent of the medical colleges are in the 6 states of Maharashtra, Karnataka, Kerala, Tamil Nadu, Andhra Pradesh and Pudicherry.
  • Whereas, just 11 percent of these are located in Bihar, Jharkhand, Orissa, West Bengal and the north-eastern states
  • 369,351 government beds are in urban areas and a mere 143,069 beds in the rural areas.
  • Rural “doctors to population” ratio is lower by 6 times as compared to urban areas.

(Source: KPMG Report 2011)

Huge healthcare Infrastructural Deficiencies:

In India, not just compared to the developed nations, even as compared BRIC countries, there is a huge infrastructural deficiencies as follows:

Indicators

Year

India

US

UK

Brazil

China
Hospital Bed Density(Per 10000 population)

2011

12

31

39

24

30
Doctor Density(Per 10000 population)

2011

6

27

21

17

14

(Source: WHO, World Health Statistics 2012)

  • 0.6 doctors per 1000 population as against the global average of 1.23 suggests an evident manpower gap in the very first stage of a treatment process.
  • Number of beds available per 1000 people in India is only 1.2, which is less than half of the global average of 2.6.

Coming to Medical Colleges, the scenario is equally dismal, as follows:

Year

Number of Medical Colleges

Total Admissions

2011-2012

314

29,263

No of dental Colleges

Total Admissions

2011-2012

289

2783

(Source: Medical Council of India & Dental Council of India)

Thus, India needs to open around 600 medical colleges (100 seats per college) and 1500 nursing colleges (60 seats per college) in order to meet the global average of doctors and nurses.

(Source: KPMG Report 2011) 

Shortages in other healthcare professionals:

It has been reported that a deficit of 64 lakh (6.4 million) allied healthcare professionals India with highest gaps in Maharashtra, Uttar Pradesh, West Bengal, Bihar and Andhra Pradesh, is a stumbling block in providing basic and quality healthcare to Indian population, as follows:

Healthcare Professionals

Shortage
Anesthetists and technicians              850,000
Dental staff              2.04 Million
Ophthalmologists and optometrists              127, 000
Rehabilitation specialists              1.8 Million
Medical laboratory technicians              61,000
Radiographers              19,000
Audiology and speech language specialists                7,500
Medical staff              230,000

(Source: Times Of India, December 20, 2012)

Is the Government ‘missing the woods for the trees’?

In a scenario like this, it is rather impractical to envisage that routine grant of compulsory licenses by the Indian Patent Office will be able to resolve the critical issue of improving access to patented medicines on a long term basis.

Not many CL granted between 1995-2012:

Despite having the provisions of CL in the Patents Act of many countries, not many CLs have been granted across the world from 1995 to date for the obvious reasons.

The details are as follows:

Country Medicine CL granted in:
Israel Hepatitis B Vaccine October 1995
Italy Imipenem (antibiotic) June 2005
Italy Sumatriptan Succinate (migraine) February 2006
Canada Oseltamivir (influenza) July 2006
Brazil Efavirenz (HIV/AIDS) May 2007
Thailand Erlotinib, Docetaxel (cancer) January 2008
India Sorafenib Tosylate (cancer) March 2012

Source: DNA, March 9, 2012

An interesting paper:

However, I hasten to add that despite all these, the provision of CL in the Indian Patents Act 2005 has immense relevance, if invoked in the right kind of circumstances.

In the paper titled ‘TRIPS, Pharmaceutical Patents and Access to Essential Medicines: Seattle, Doha and Beyond’, published in ‘Chicago Journal for International Law, Vol. 3(1), Spring 2002’, the author argues, though the reasons for the lack of access to essential medicines are manifold, there are many instances where high prices of drugs deny access to needed treatments for many patients. Prohibitive drug prices, in those cases, were the outcome of monopoly due to strong intellectual property protection.

The author adds, “The attempts of Governments in developing countries to bring down the prices of patented medicines have come under heavy pressure from industrialized countries and the multinational pharmaceutical industry”.

Right pricing of patented drugs is critical: 

While there is no single or only right way to arrive at the price of an IPR protected medicine, how much the pharmaceutical manufacturers will charge for such drugs still remains an important, yet complex and difficult issue to resolve, both locally and globally. Even in the developed nations, where an appropriate healthcare infrastructure is already in place, this issue comes up too often mainly during price negotiation for reimbursed drugs.

A paper titled, “Pharmaceutical Price Controls in OECD Countries”, published by the US Department of Commerce after examining the drug price regulatory systems of 11 OECD countries concluded that all of them enforce some form of price controls to limit spending on pharmaceuticals. The report also indicated that the reimbursement prices in these countries are often treated as de facto market price.

In India, the Government is already mulling to put in place a similar mechanism for patented medicines, as captured in the NPPP 2012.

Further, some OECD governments regularly cut prices of even those drugs, which are already in the market. The values of health outcomes and pharmacoeconomics analysis are gaining increasing importance for drug price negotiations/control by the healthcare regulators even in various developed markets of the world to ensure responsible pricing of IPR protected medicines.

An evolving global trend:

To address such pricing issues, global pharmaceutical majors, like GSK and Merck (MSD) have already started following the differential pricing model, based primarily on the size of GDP and income status of the people of the respective countries. This strategy includes India, as well.

Reference pricing model is yet another such example, where the pricing framework of a pharmaceutical product will be established against the price of a reference drug in reference countries.

An innovative approach to address patented products’ pricing:

To effectively address the challenge of pricing of patented medicines in India, Swiss drug major Roche, has reportedly entered into a ‘never-before’ technology transfer and manufacturing contract for biologics with a local Indian company – Emcure Pharma, for its two widely acclaimed Monoclonal Antibodies’ anti-cancer drugs – Herceptin and MabThera.

The report says that in the past, Emcure had signed licensing deals with US-based bio-pharmaceutical drug maker Gilead Life Sciences for Tenafovir and with Johnson and Johnson for Darunavir. Both are anti-HIV drugs.

In this regard, media reports further indicated that Roche would offer to Indian patients significantly cheaper, local branded versions of these two anti-cancer drugs by early this year. The same news item also quoted the Roche spokesperson from Basel, Switzerland commenting as follows:

“The scope is to enable access for a large majority of patients who currently pay out of pocket as well as to partner with the government to enable increased access to our products for people in need”.

Such ‘out of box’ strategies and initiatives by the global innovator companies could help keeping prices of patented products affordable to the Indian patients, improving their access significantly and making the likes of the current Government initiative on CL irrelevant. 

Conclusion:

It is generally accepted that the provisions for CL in the Indian Patents Act 2005 has utmost relevance in terms of public health interest for all concerned.

However, keeping in view of recent policy announcement in the NPPP 2012, as approved by the Union Cabinet, on price negotiation for patented products, the reported Government move of invoking these provisions for three anti-cancer drugs is rather intriguing.

Moreover, even for the cancer patients, there seems to be a greater urgency to attend to basic healthcare infrastructural and delivery issues, besides providing Universal Health Coverage  (UHC) as recommended by the High Level Experts Group (HLEG) constituted for this purpose by the Government.

Far encompassing critical decisions like grant of CL, I reckon, should be taken only after exhausting all other access improvement measures.

Thus, recent news reports on the possibility of further grant of three more CLs could make the pharmaceutical business environment for the innovator companies in India more uncertain.

Demonstrable predictability for an innovation friendly environment is critical for the economic growth of India, which the Government should not lose sight of. Just upping the ante for more CL of anti-cancer drugs will not necessarily help improving access to cancer treatments in India.

By: Tapan J. Ray

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

To accelerate increasing ‘Access to Modern Medicines’ in India: A Strategic Approach

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Currently no one knows what the ‘Access to Modern Medicines’ in India is, in real term. Like many others, both local and global. I myself was quoting the World Medicines Situation of 2004 report, the base year of which is actually 1999. Thus there should not be even an iota of doubt in anybody’s mind that the above reported situation has changed quite significantly during the last decade in India and the statement that both the government and the industry alike has been making since then, ‘only 35% of the population of the country, against 53% in Africa and 85% in China has access to modern medicines’, is indeed quite dated. It does not make sense, at all, in the recent times of the Pharmaceutical industry in India.

More surprisingly, an updated information on the subject does not seem to be available anywhere, as yet, not even with the World Health Organization (WHO). However, the good news is, it has been reported that the ‘World Medicines Situation’ is currently being updated by the WHO.

 Access to modern medicines is improving in India:

Be that as it may, CAGR volume growth of the pharmaceutical industry since the last ten years has been around 10%, leave aside another robust growth factor being contributed through the introduction of new products, every year. Encouraging growth of the Indian Pharmaceutical Market (IPM), since the last decade, both from the urban and the rural areas certainly signals towards significant increase in the domestic consumption of medicines in India. In addition, extension of focus of the Indian pharmaceutical Industry, in general, to the fast growing rural markets clearly supports the argument  of increasing ‘Access to Modern Medicines’ in India. The improve in access may not exactly be commensurate to the volume growth of the industry during this period, but a major part of the industry growth could certainly be attributed towards increase in access to medicines in India.

For arguments sake, out of this rapid growth of the IPM, year after year consistently, if I attribute just 5% of the growth per year, for the last nine year over the base year, to improved access to medicines, it will indicate, at least, 57% of the population of India is currently having access to modern medicines and NOT just 35%, as I wrote in this blog earlier.

Unfortunately, even the Government of India does not seem to be aware of this gradually improving trend. Official communications of the government still quote the outdated statistics, which states that 65% of the population of India does not have ‘Access to Modern Medicines’ even today. No wonder, why many of us still prefers to live on to our past.

Be that as it may, around 43% of the population will still not have ‘Access to Medicines’ in India. This issue needs immediate attention of the policy makers and can be achieved with a holistic approach to resolve this issue. A robust model of healthcare financing for all socio-economic strata of the population, further improvement of healthcare infrastructure and healthcare delivery systems are the need of the hour.

Percentage growth in the healthcare budget is higher than that of the GDP:

With the increase of healthcare expenditure by 15% for 2008-09 and further increase in 2010-11, as announced by the Finance Minister in his recent Budget Speech, the healthcare expenditure as a percentage to GDP still remains around 1.0%, which is quite inadequate to address the key healthcare issues of the country.

The Prime Minister has already has expressed his intent that India will be able to increase its public healthcare spend to around 2.5% of the GDP, when GDP growth will touch the double digit figure of 10%, which I reckon, is no longer a pipe dream.

Explore a Public-Private Partnership (PPP) with the stakeholders of the Pharmaceutical Industry:

To address the critical issue of access to modern medicines, policy makers should now actively consider a series of closely integrated PPP initiatives. These PPP initiatives will initially include ‘Below the Poverty Line’ (BPL) families of our country, which not only constitute a significant part of our population, but also will have almost nil purchasing power for medicines. Thereafter, the scheme, slightly modified, should be extended to all ration card holders in India.

Possible impact of such PPP initiatives on improving access to medicines:

If such PPP initiatives are carefully and innovatively strategized, carefully planned and diligently executed, the access to modern medicines in India could increase from current 57% to over 63% of our population within a year’s time  and to over 82% of the population over a period of next five years.

A ‘Back of the Envelope’ Strategy Outline:

The Objective:

To improve access to medicines to over 60% of the population one year after the execution of the strategy and to over 80% within the next five years. The key stakeholders, especially the pharmaceutical companies in India, will work closely with the Government under PPP initiatives for the improvement of access to modern medicines initially to the BPL families, significantly, who have almost no purchasing power for medicines.

The Plan:

- The stakeholders, mainly the pharmaceutical industry, to work out a suitable methodology to help the Government to reach all pharmaceutical formulations covered under ‘National List of Essential Medicines (NLEM)’ to the BPL families across the country and gradually extend it to all ration card holders in India.

- The government would extend appropriate Tax cuts to the concerned companies, as an incentive towards their involvement in the PPP initiatives.

- The National Pharmaceutical Pricing Authority (NPPA) would continue to strictly implement its drug price monitoring mechanism for all categories of drugs to keep their prices well under control, always.
Key Assumptions:
- According to Planning Commission of India (2007) the population of India is 116.9 Crore or 1.169 billion.

- According to ‘Centre for Science & Environment (August 2007)’ the latest figures on poverty place 27% of India’s population below the poverty line (BPL) out of which 72% reside in rural areas.

- No price of medicines will be affordable to the BPL families.

- The National Sample Survey Organization (NSSO) report on “Public Distribution System & Other Sources of Household Consumption, 2004 – 05” shows that only 28% of the rural poor have benefited from any type of government food assistance schemes, including ‘Public Distribution System’ and for urban areas the figure is just 9.5%. That means about 72 Million people below the poverty line are having ration cards.

- According to 1995 World Bank Study, the established per capita health spending is around Rs.320 per year.

- McKinsey in their report “India Pharma 2015” has stated that expenditure on medicines is 15% of total healthcare spend i.e. Rs.48 per year.

Methodology:

- Identify the number of BPL families who hold ration cards to receive free/subsidized medicine.

- Determine the cost to be incurred by the Government for purchase of medicines under NLEM.

- Devise a system of generating commensurate funds to improve access to BPL families.

- Operationalize the distribution of medicines to BPL families with public transparency

- Increase penetration of ‘Jan Aushadhi’ outlets simultaneously as a supportive incremental measure

Projected increase in ‘Access to NLEM Drugs’:

Million
Population of India

1169
27% of Population is BPL

316
72% rural

228
28% urban

88
28% of 228 million have ration cards

64
9.5% of 88 million have ration cards

8
Total BPL ration card holders

72
Current Access to Modern medicines of 57%

666
When all ration card holders get NLEM drugs the access improves to:

738

�
SO, IF AT LEAST THE BPL RATION CARD HOLDERS GET NLEM MEDICINES, ACCESS IMPROVES FROM 57% TO 63.2%.

Cost implications of Increasing Access from 57% to 63.2%:

  1.  72 million ration card holders will need Rs.48 worth medicines per year i.e. Rs.3456 million or Rs.346 Crores.
  2. If Industry contributes 0.6% of its turnover which will attract full tax (both direct and indirect) exemptions from the Government, the industry contribution works out to Rs.170 Crores.
  3. A similar amount should be provided by the Government for purchase of free/subsidized medicines for exclusive dispensing to the BPL families.

To operationalize improved ‘Access to Medicines’:

- All ration card holders to be provided with a separate card (if not a smart card) for issue of medicines with a Unique Identification Number.

- Each ration shop will have a separate counter named ‘Jan Aushadhi’ for medicine, which will cater to only registered BPL families.

- Government to arrange to train the Ration Shop owners/employees in Pharmaceutical storage and dispensing

- Doctors of Primary Healthcare Centers, Block Dispensaries will be directed to provide free treatment and prescribe NLEM medicines to the members of BPL families holding such ration cards.

- Subsidized/free supply of medicines will be made against prescriptions from the ‘Jan Aushadhi’ counters of the Ration Shops to these families.

- The doctors’ prescriptions with a copy of the bill will be retained by the respective Ration Shops to account for such purchases of medicines by the BPL families.

- More & more members of BPL family will be encouraged to register for ration cards and be eligible for free / subsidized medicines.

Conclusion:

On completion of this scheme for BPL families and after covering all ration card holders, overall the access to modern medicines in India could increase from 57% to over 80% over a period of 5 years.

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.

 

 

The need for urgent healthcare reform in India: The way forward.

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If we look at the history of development of the developed countries of the world, we shall see that all of them had invested and even now are investing to improve the social framework of the country where education and health get the top priority. Continuous reform measures in these two key areas of any nation, have proved to be the key drivers of their economic growth.Very recently we have witnessed some major reform measures in the area of ‘primary education’ in India. The right to primary education has now been made a fundamental right of every citizen of the country, through a constitutional amendment.As focus on education is very important to realize the economic potential of any nation, so is the healthcare space of the country. India will not be able to realize its dream to be one of the economic superpowers of the world without sharp focus and significant resource allocation in these two areas.

Healthcare in India:

There are various hurdles though to address the healthcare issues of the country effectively, but these are not definitely insurmountable. National Rural health Mission is indeed an admirable scheme announced by the Government. However, many feel that poor governance will not be able make this scheme to become as effective as it should be. Implementation of such schemes warrants effective leadership at all levels of implementation. Similar apprehensions can be extended to many other healthcare initiatives including the health insurance program for below the poverty line (BPL) population of the country.

A quick snapshot on the overall healthcare system of India:

In terms of concept, India has a universal healthcare system where health is primarily a state subject.

Primary Health Centres (PHCs) located in the cities, districts or rural areas provide medical treatment free of cost to the citizens of the country. The focus areas of these PHCs, as articulated by the government, are the treatment of common illnesses, immunization, malnutrition, pregnancy and child birth. For secondary or tertiary care, patients are referred to the state or district level hospitals.

The public healthcare delivery system is grossly inadequate and does not function with a very high degree of efficiency, though some of the government hospitals like, All India Institute of Medical Science (AIIMS) are among the best hospitals in India.

Most essential drugs, if available, are dispensed free of charge from the public hospitals/clinics.
Outpatient treatment facilities available in the government hospitals are either free or available at a nominal cost. In AIIMS an outpatient card is available at a nominal onetime fee and thereafter outpatient medical advice is free to the patient.

However, the cost of inpatient treatment in the public hospitals though significantly less than the private hospitals, depends on the economic condition of the patient and the type of facilities that the individual will require. The patients who are from below the poverty line (BPL) families are usually not required to pay the cost of treatment. Such costs are subsidized by the government.

However, in India only 35 percent of the population have access to affordable modern medicines. The healthcare facilities in the public sector are not only grossly inadequate, but also understaffed and underfinanced. As a result, whatever services are available in most of the public healthcare facilities, are of substandard quality to say the least, which compel patients to go for expensive private healthcare providers. Majority of the population of India cannot afford such high cost of private healthcare providers though of much better quality.

A recent report on healthcare in India:

A recent report published by McKinsey Quarterly , titled ‘A Healthier Future for India’, recommends, subsidising health care and insurance for the country’s poor people would be necessary to improve the healthcare system. To make the healthcare system of India work satisfactorily, the report also recommends, public-private partnership for better insurance coverage, widespread health education and better disease prevention.

The way forward:

In my view, the country should adopt a ten pronged approach towards a new healthcare reform process:

1. The government should assume the role of provider of preventive and primary healthcare across the nation.

2. At the same time, the government should play the role of enabler to create public-private partnership (PPP) projects for secondary and tertiary healthcare services at the state and district levels.

3. Through PPP a robust health insurance infrastructure needs to be put in place, very urgently.

4. These insurance companies will be empowered to negotiate all fees payable by the patients for getting their ailments treated including doctors/hospital fees and the cost of medicines, with the concerned persons/companies, with a key objective to ensure access to affordable high quality healthcare to all.

5. Create an independent regulatory body for healthcare services to regulate and monitor the operations of both public and private healthcare providers/institutions, including the health insurance sector.

6. Levy a ‘healthcare cess’ to all, for effective implementation of this new healthcare reform process.

7. Effectively manage the corpus thus generated to achieve the healthcare objectives of the nation through the healthcare services regulatory authority.

8. Make this regulatory authority accountable for ensuring access to affordable high quality healthcare services to the entire population of the country.

9. Make operations of such public healthcare services transparent to the civil society and cost-neutral to the government, through innovative pricing model based on economic status of an individual.

10. Allow independent private healthcare providers to make reasonable profit out of the investments made by them

By Tapan Ray

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