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Pharma’s Digital Initiatives In India: A Missing Link

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An interesting study – designed to investigate the challenges that Health and Human Services (HHS) organizations face in implementing digital and data solutions, stands out today – for many reasons. One such being, this ‘multi-country survey’ project team had no inkling about the pandemic when the project was undertaken.

This study was conducted by a research team from Imperial College London’s Institute of Global Health Innovation (IGHI), and was sponsored by EY. The survey comprises of more than 2,000 global HHS professionals – from India, Australia, Italy, UAE, the UK and the US. 359 respondents were from India.

The research passed through the phase when Covid related disruptions was about to put HHS providers through the most extreme stress test in living memory. ‘While the outbreak was catastrophic in its effects, it presented the researchers with an exceptional opportunity to study the sector’s behavior during a pivotal moment,’ the paper noted.

From this perspective, today’s article will explore, from various different sources, across the world, how Covid-triggered rapid development and adoption of digital solutions are in the process of making a paradigm shift in the healthcare space. It spans across – health care service providers, its users, and practitioners – including pharma industry and the tech-solution developers.

Consequently, the question arises, would healthcare industry’s innovative spirit of 2020 is robust enough for taking a quantum leap in this space, as we move on. That space will span across – conceptualization and development of new health care products and services, alongside their consumption pattern and consumer behavioral dynamics. And, right up to the adoption of cutting-edge digital technology for commensurate delivery mechanisms. Let me start with some key findings in this area from the above report.

Some key findings – Global and India:

The findings of the Report titled, ‘Embracing digital: is COVID-19 the catalyst for lasting change?’ published on January 13, 2021, ferreted out some interesting facts, with details. These encompass both global and Indian scenario, in this area.

Some key findings – Global:

  • Pre-pandemic – just 18% of HHS providers had managed to embed digital tools in the way they work – mostly, due to lack of funds, regulatory restrictions, and risk aversion. However, the pandemic outbreak swept away many of these barriers, as 62% of organizations have now started using digital technologies and data solutions, globally.
  • 48% organizations are planning to continue investing in technology during the next three years, with 33% expecting more than 50%, and 19% more than 100% increase in investment.
  • While phone consultations are being offered by 81 % of HHS organizations (up from 39 % before the pandemic), 71 % of organizations offering video consultations (up from 22 % before the pandemic).
  • Respondents’ top objectives for future investment towards rapid adoption of digital solutionsinclude, transforming ways of working and service delivery, improving quality of care, reducing the administrative load, enabling better communications, and streamlining work processes.
  • However, 47% of respondents think, the introduction of digital and data solutions was a temporary measure to address challenges during the pandemic.

Some key findings – India:

The Covid-19 pandemic triggered fast acceleration of the adoption of digital technologies by the HHS in India, as well.

  • 51% of respondents from India reported that their respective organizations have increased the use of digital technologies and data solutions since the Covid-19 outbreak.
  • Increased staff productivity reported for 74 % of respondents’ organizations with 75% reporting that digital solutions have been effective in delivering better outcomes for patients and service users.
  • Remote consultations, such as, phone and video consultations have witnessed a greater increase in India than the global average. 86 % of Indian organizations are now offering phone consultation (up from 48 % before pandemic) and 83 % for video consultations (up from 33 % before pandemic).
  • Around three fourth of the respondents in India reported positive experiences with digital technologies and data solutions with the number of people using online consultations in India recording a threefold increase.

This encouraging trend and pattern needs to be consolidated, analyzed, and leveraged – for sharper actionable insights for the development of more contemporary products and services to delight the pharma and health care stakeholders.

A key missing link in India:

The digital health transformation of India’s healthcare system during Covid pandemic was also captured in another article, published by Elsevier Connect on February 23, 2021. It reiterated, although the pandemic has made an overall detrimental impact impacted on India, ‘it has brought about an avalanche of positive changes, including the adoption of digital health technologies and significant changes to the way care is delivered.’ Looking ahead, ‘With the launch of national public health initiatives, India has an incredible opportunity to become a digital health leader,’ the paper predicted.

However, the author also pointed out, unambiguously, that the health care crisis caused by the pandemic has also brought to the fore a key missing link – the need for updated and near real-time availability of trusted information. This observation is more relevant now than ever before, especially considering India’s National Digital Health Mission (NDHM).

National Digital Health Mission – a new ambition:

While addressing the nation on August 15, 2020, Prime Minister Narendra Modi announced the National Digital Health Mission of India. He said in his speech, “From today, the national digital health mission will begin. It will revolutionize the Indian healthcare sector. Every Indian will be issued a health ID that will act like a healthcare account, storing details of all the tests done, existing diseases, diagnoses, medicines prescribed.”

The objectives of the mission are to establish a core digital health database, creating a system of Electronic Health Records (EHR) based on international standards, establish data ownership pathways, so that patients become the owner of their health records, and promoting health data analytics and medical research. This initiative by any standard, is expected to be a game changer, as and when it comes to fruition.

Subsequently, on June 25, 2020, the Union Ministry of Health, reportedly, wrote to the principal secretaries (health) of all states and union territories, asking them to extend full support to the NHA to create four registries — doctors, health infrastructure, health IDs and personal health records of patients. It also instructed the states to send the required details within the stipulated timeline without breaching the norms of data privacy.

Need to avoid any possible missing link in the NDHM:

However, the Harvard Business Review article, published on June 12, 2020, asserted that the emergence of the COVID-19 pandemic not only presented a “mind-boggling array of challenges” exposed the limitations of the electronic health record (EHR) in helping physicians deliver care, especially in the United States.

It suggested: transformation of the EHR from an emphasis on a ‘person’s medical record’ – to an emphasis on their ‘plan for health’ and from a focus on ‘supporting clinical transactions’ to a focus on ‘delivering information’ to the provider and the patient, will be more meaningful.

Thus, it’s time for a new kind of EHR system in today’s perspective, as suggested by the HBR article, besides other domain experts. I am sure, competent authorities will take note of this transformation required in EHR initiatives to avoid any missing link in the new digital healthcare space in India.

As the above Elsevier Connect paper also observed, with the launch of national public health initiatives, such as, Ayushman Bharat and National Digital Health Mission (NDHM), India harbors an incredible opportunity to showcase its world class digital health ecosystem for all in the country.

To help fructify these projects, all key stakeholders – health care service providers, its users, and practitioners – including the pharma industry and the tech solution companies, need to get intimately involved with a common agenda in place. Falling behind may invite regrets, later.

Nonetheless, well before that – the common missing links in India - near real-time availability of credible data, trusted and verified information for adopting digital health for patients that will need to be provided by clinicians in a seamless manner, should be carefully identified and addressed.

New steps into digital healthcare are on the way:

Several new steps into digital healthcare have been taken in various countries of the world. One such initiative is ‘Internet Hospitals.’ These are basically an internet-medical-platform combining online and offline access for medical institutions to provide a variety of telehealth services directly to patients.

A Deloitte paper – ‘Internet Hospitals in China: The new step into digital healthcare,’ published on March 16, 2021 says: ‘Online hospitals are typically offshoots of offline medical organizations. The combination of Internet with health care will drive the medical industry’s transformation into a health service provider from a health care supplier, distributing resources equally and enhancing efficiency,’ moving ‘towards future smart health care.’

Conclusion:

Covid-19 has created a new focus on the digital health ecosystem in India, for accelerating the use of digital technology to radically advance health care systems and save lives. Today, many are experiencing that, big data, analytics, artificial intelligence, remote learning, and data inter-connectivity, can make a real difference to the work of HHS professionals in India.

Embracing digital with accelerated speed during the pandemic, has reportedly started making a significant positive impact on the cycle of the patient’s clinical assessment, treatment, and monitoring. With increasing use, it would reduce the cost of health care, improve patient access to affordable treatment and care services, when many patients’ journey for disease treatment will start online, and get directed to the optimal care setting either physically or virtually.

The article on health-tech, published in the Fortune India on February 20, 2021, has aptly concluded: ‘Eventually health technology infusion in the Indian healthcare ecosystem will be the route to enhance patient-centric healthcare accessibility, affordability, and sustainability. The advent of 5G technology in the country is poised to further catalyze this momentum.’ This, in turn, will facilitate ushering in more game changing steps into digital healthcare, creating a new ecosystem, greater awareness and a keen desire to remain healthy for all.

Thus, from the GIGO perspective, as defined by the Cambridge Dictionary, I reckon, in pharma’s digital initiatives, especially in India, a key factor needs to be carefully addressed. This is – fathoming existence of any missing link involving near real-time availability of trusted information and credible data generation, which could indeed be a great spoiler of any painstaking digital adoption project.

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.

 

 

Rebuilding Pharma Image: A Laudable Mindset – Lacking In Many

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The fierce debate on ethics and compliance related issues in the pharma marketing practices still reverberates, across the globe. One of its key fallout has been ever-increasing negative consumer perception about this sector, sparing a very few companies, if at all. As a result, many key communications of the individual players, including the industry associations specifically targeted to them, are becoming less and less credible, if not ineffective.

Which is why, though pharma as an industry is innovative in offering new medicines, consumers don’t perceive it so. Despite several drug players’ taking important steps towards stakeholder engagement, consumers don’t perceive so. The list goes on and on. I discussed on such consumer perception in my article of June 26, 2017. Hence, won’t further go into that subject, here.

General allegation on the pharma industry continues to remain unchanged, such as the drug industry tries to influence the medical profession, irrespective of whether they write prescription drugs for patients or are engaged in regulatory trial related activities aimed at product marketing.

Let me give an example to illustrate the later part of it, and in the Indian context. On April 26, 2017, it was reported that responding to a joint complaint filed by Mylan and Biocon in 2016, alleging that the Roche Group indulged in “abusive conduct”, the Competition Commission of India (CCI) gave directions for carrying out a detailed investigation on the subject. This probe was initiated to ascertain, whether Roche used its dominant position to maintain its monopoly over the breast cancer drug Trastuzumab, adversely impacting its access to many patients.

Such a scenario, though, undoubtedly disturbing, is very much avoidable. Thus, winning back the fading trust of the consumers in the industry, should be ticked as a top priority by the concerned parties.

In this article, I shall mostly focus on some recent developments related to ethics and compliance issues, mainly in pharma marketing, and with a small overlap on the regulatory and other areas, as and when required to drive home a point.

It shakes the trust base on the medical profession too:

This menace, as it were, though, more intense in India, is neither confined to its shores alone, nor just to the pharma industry, notwithstanding several constituents of big pharma have been implicated in mega bribery scandals in different countries. There doesn’t seem to be much doubt, either, that its impact has apparently shaken the very base of trust even on the medical profession, in general.

Not very long ago, Dr. Samiran Nundy, while holding the positions of Chairman, Department of Surgical Gastroenterology and Organ Transplantation at Sir Ganga Ram Hospital and Editor-in-Chief of the Journal of Current Medicine Research and Practice, reportedly exposed the widespread malpractices of the doctors in India who are taking cuts for referrals and prescribing unnecessary drugs, investigations and procedures for profit.

This practice continues even today, unabated. On June 18, 2017, it was widely reported in India that Maharashtra Government has decided to form a 3-member committee for suggesting effective ways to check the ‘cut practice’ of doctors. This decision followed a public awareness campaign on this subject, initiated by well-reputed late heart surgeon – Dr. Ramakanta Panda’s Asian Heart Institute, located in Mumbai. The hospital had put up a hoarding saying: ‘No commission. Only honest medical opinion’. The Indian Medical Association opposed the hoarding. But the hospital wrote to Maharashtra medical education minister seeking a legislation to fight this malpractice.

To contain this malady across India, for the sake of patients, Dr. Nundy had then suggested that to begin with, “The Medical Council of India (MCI), currently an exclusive club of doctors, has to be reconstituted. Half the members must be lay people like teachers, social workers and patient groups like the General Medical Council in Britain, where, if a doctor is found to be corrupt, he is booted out by the council.”

This subject continues to remain an open secret, just as pharma marketing malpractices, and remains mostly confined to the formation of various committees.

“Corruption ruins the doctor-patient relationship in India” – a reconfirmation:

“Corruption ruins the doctor-patient relationship in India” - highlighted an article published in the British Medical Journal (BMJ) on 08 May 2014. Its author – David Berger wrote, “Kickbacks and bribes oil every part of the country’s health care machinery and if India’s authorities cannot make improvements, international agencies should act.”

He reiterated, it’s a common complaint, both of the poor and the middle class, that they don’t trust their doctors from the core of hearts. They don’t consider them honest, and live in fear of having no other choice but to consult them, which results in high levels of doctor shopping. David Berger also deliberated on the widespread corruption in the pharmaceutical industry, with doctors bribed to make them prescribe specified drugs.

The article does not fail to mention that many Indian doctors do have huge expertise, are honorable and treat their patients well. However, as a group, doctors generally have a poor reputation.

Until the medical profession together with the pharma industry is prepared to tackle this malady head-on and acknowledge the corrosive effects of medical corruption, the doctor-patient relationship will continue to lie in tatters, the paper says.

Uniform code of ethical pharma marketing practices:

This brings us to the need of a uniform code of ethical pharma marketing practices. Such codes, regardless of whether voluntary or mandatory, are developed to ensure that pharma companies, either individually or collectively, indulge in ethical marketing practices, comply with all related rules and regulations, avoid predominantly self-serving goals and conflict interest with the medical profession, having an adverse impact on patients’ health interest.

This need was felt long ago. Accordingly, various pharma companies, including their trade associations, came up with their own versions of the same, for voluntary practice. As I wrote before, such codes of voluntary practice, mostly are not working. That hefty fines are being levied by the government agencies in various countries, that include who’s who of the drug industry around the world, with India being a major exception in this area, would vindicate the point.

Amid all these, probably a solitary global example of demonstrable success with the implementation of voluntary codes of ethical pharma marketing practices, framed by a trade association in a major western country of the world, now stands head and shoulders above others.

Standing head and shoulders above others:

On June 23, 2017, the international business daily – ‘Financial Times’ (FT), reported: “Drug maker Astellas sanctioned for ‘shocking’ patient safety failures”

Following ‘a series of shocking breaches of guidelines’ framed by ‘The Prescription Medicines Code of Practice Authority (PMCPA)’ – an integral part of the ‘Association of the British Pharmaceutical Industry (ABPI)’, publicly threatened the Japanese drug major – Astellas, for a permanent expulsion from the membership of the Association. However, PMCPA ultimately decided to limit the punishment to a 12-month suspension, after the company accepted its rulings and pledged to make the necessary changes. Nevertheless, Astellas could still be expelled, if PMCPA re-audit in October do not show any “significant progress” in the flagged areas – the report clarified.

Interestingly, just in June last year, ABPI had suspended Astellas for 12 months ‘because of breaches related to an advisory board meeting and deception, including providing false information to PMCPA’. The company had also failed to provide complete prescribing information for several medicines, as required by the code – another report highlights.

Astellas is one of the world’s top 20 pharmaceutical companies by revenue with a market capitalization of more than £20bn. In 2016 its operations in Europe, the Middle East and Africa generated revenues of €2.5bn –reports the FT.

What is PMCPA?

One may be interested to fathom how seriously the implementation of the uniform code of pharmaceutical marketing practice is taken in the United Kingdom (UK), and how transparent the system is.

The Prescription Medicines Code of Practice Authority (PMCPA) is the self-regulatory body which administers the Association of the British Pharmaceutical Industry’s (ABPI) Code of Practice for the Pharmaceutical Industry, independent of the ABPI. It is a not-for-profit body, which was established by the ABPI on 1 January 1993. In other words, the PMCPA is a division of the British pharma trade association – ABPI.

According to PMCPA website, it:

  • Operates the complaints procedure under which the materials and activities of pharmaceutical companies are considered in relation to the requirements of the Code.
  • Provides advice and guidance on the Code.
  • Provides training on the Code.
  • Arranges conciliation between pharmaceutical companies when requested to do so.
  • Scrutinizes samples of advertisements and meetings to check their compliance with the Code.

As I often quote: ‘proof of the pudding is in eating’, it may not be very difficult to ascertain, how a constructive collective mindset of those who are on the governing board of a pharma trade association, can help re-creating the right image for the pharma industry, in a meaningful way.

Advertisements and public reprimands for code violations:

The PMCPA apparently follows a system to advertise in the medical and pharmaceutical press brief details of all cases where companies are ruled in breach of the Code. The concerned companies are required to issue a corrective statement or are the subject of a public reprimand.

For the current year, the PMCPA website has featured the details of three ABPI members as on May 2017, namely, Gedeon Richter, Astellas, and Gedeon Richter, for breaching the ethical code of practices.

However, in 2016, as many as 15 ABPI members featured in this list of similar violations. These are:  Vifor Pharma, Celgene, Takeda, Pierre Fabre, Grünenthal Ltd, Boehringer Ingelheim Limited, Eli Lilly, AstraZeneca, Janssen-Cilag, Astellas, Stirling Anglian, Guerbet, Napp, Hospira, Genzyme, Bausch & Lomb and Merck Serono. It is worth noting that the names of some these major companies had appeared more than once, during that year.

I am quoting the names of those companies breaching the ABPI code, just to illustrate the level of transparency in this process. The details of previous years are available at the same website. As I said, this is probably a solitary example of demonstrable success with the implementation of voluntary practices of ethical pharma marketing codes, framed by any pharma trade association.

In conclusion:

Many international pharmaceutical trade associations, which are primarily the lobbying outfits, are known as the strong votaries of self-regulations of the uniform code of ethical pharma marketing practices, including in India. Some of them are also displaying these codes in their respective websites. However, regardless of all this, the ground reality is, the much-charted path of the well-hyped self-regulation by the industry to stop this malaise, is not working. ABPI’s case, I reckon, though laudable, may well be treated as an exception. 

In India, even the Government in power today knows it and publicly admitted the same. None other than the secretary of the Department of pharmaceuticals reportedly accepted this fact with the following words: “A voluntary code has been in place for the last few months. However, we found it very difficult to enforce it as a voluntary code. Hence, the government is planning to make it compulsory.”

Following this, as reported on March 15, 2016, in a written reply to the Lok Sabha, the Minister of State for Chemicals and Fertilizers, categorically said that the Government has decided to make the Uniform Code of Pharmaceutical Marketing Practice (UCPMP) mandatory to control unethical practices in the pharma industry.

The mindset that ABPI has demonstrated on voluntary implementation of their own version of UCPMP, is apparently lacking in India. Thus, to rebuild the pharma industry image in the country and winning back the trust of the society, the mandatory UCPMP with a robust enforcement machinery, I reckon, is necessary – without any further delay.

However, the sequence of events in the past on the same, trigger a critical doubt: Has the mandatory UCPMP slipped through the crack created by the self-serving interest of pharma lobbyists, including all those peripheral players whose business interests revolve round the current pharma marketing practices. Who knows?

Nonetheless, the bottom line remains: the mandatory UCPMP is yet to be enforced in India… if at all!

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.

Small Steps, yet Giant Leaps: In Pursuit of Affordable Medicines for All

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Since last few years, some small yet very significant steps are being taken, mostly by the respective Governments, in and outside India, to provide affordable healthcare in general and affordable medicines in particular, for all.

It is well recognized that drug prices play as critical a role as a robust healthcare infrastructure and quality of its delivery system to provide affordable healthcare to the general population of any country. Thus, it is not a ‘chicken and egg’ situation. All these issues must be addressed simultaneously and with equally great care.

A WHO report:

A World Health Organization (WHO) titled, “Improving access to medicines through equitable financing and affordable prices” highlights as follows:

“In many countries medicines account for over half of total health expenditures and are often unavailable and unaffordable to consumers who need them. Up to 90% of the population in developing countries still buys medicines through out-of-pocket payments, and are often exposed to the risk of catastrophic expenditure.”

Definition of ‘Access to Medicines’:

How then one will define ‘access to medicines’?

United Nations Development Group, in a paper titled ‘Indicators for Monitoring the Millennium Development Goals (United Nations, New York, 2003) defined  ‘Access to Medicines’ as follows:

‘Having medicines continuously available and affordable at public or private health facilities or medicine outlets that are within one hour’s walk from the homes of the population.’

Healthcare ‘affordability’ is critical:

Despite healthcare infrastructure in India being inadequate with a slow pace of development, affordability of healthcare, including medicines, still remains critical. 

This is mainly because, even if a quality healthcare infrastructure together with an efficient delivery system is put in place without ensuring their affordability, patients’ access to quality healthcare products and services will not improve, especially in India, where private healthcare dominates.

Diversionary measures should not cause distraction:

Although, maximum possible resources must be garnered to address the critical issue of expanding quality healthcare infrastructure and delivery system sooner, the focus of the government, as stated above, must not get diverted from making healthcare products and services affordable to patients, at any cost.

This should continue despite diversionary measures from some quarter to deflect the focus of all concerned from affordability of healthcare to lack of adequate healthcare infrastructure and its delivery mechanisms in India.

This, in no way, is an ‘either/or’ situation. India needs to resolve both the issues in a holistic way, sooner.

Small Steps:

In an earnest endeavor to provide affordable medicines to all, the following small and simple, yet significant steps have been taken in and outside India:

  1. Strong encouragement for generic drugs prescriptions
  2. Regulatory directive for prescriptions in generic names
  3. In case that does not work – Government initiative on Patient Empowerment

In this article, I shall try to capture all these three small steps.

1. Strong encouragement for generic drugs prescriptions:

A. Generic drugs improve access and reduce healthcare cost:

A Special Report From the ‘US-FDA Consumer Magazine’ and the FDA Center for Drug Evaluation and Research, Fourth Edition / January 2006 states that generic drugs offer significant savings to the consumers.

Quoting a 2002 study by the Schneider Institute for Health Policy at Brandeis University in Waltham, Mass., it reiterated that if Medicare increased the rate of generic usage to that of similar high-performing private sector health plans, its 40 million beneficiaries could see potential savings of US$14 billion.

Another US-FDA report titled, ‘Greater Access to Generic Drugs’ also reinforced the argument that rising costs of prescription drugs remain a major challenge for consumers, especially older Americans. To address this issue effectively generics can play a critical role by providing less expensive medications.

B. ‘Obamacare’ followed this direction resulting decline in spend on high priced Patented Drugs:

Recently The New York Times quoting IMS Health reported that nationwide turnover of patented drugs in the U.S actually dropped in 2012. This decline though was just by 1 percent to US$ 325 billion, is indeed very significant and happened due to increasing prescription trend for low cost generics across America since past several years.

It is interesting to note this trend in America where the cost of medicines account for just about 15 percent (against over 70 percent in India) of the nation’s health care expenditures.

IMS Health reported that in 2012, 84 percent of all prescriptions were dispensed as generics and estimated use of generics may reach even as high as 86 to 87 percent in the U.S.

However, many experts believe that this trend is a result of many blockbusters like Lipitor going off patent during this period and no major breakthrough medicines coming with perceptible added value in these large therapy areas.

That said, lesser number of small molecule blockbuster drugs is set to lose patent protection over the next several years and the complexity in manufacturing and getting marketing approvals of large molecule biosimilar drugs in the U.S could arrest this trend.

Biosimilar drugs though are available in European Union, are expected to be available in the America not before at least two more years.

Despite a sharp increase in prescriptions for generic drugs, some of the patented medicines came with ‘jaw-dropping’ price tags: four drugs approved in 2012 carry a yearly cost of more than US$ 200,000 per patient, though the cost of development of some of these drugs do not exceed US$ 250 million, as reported by Forbes.

2. Regulatory directive for prescriptions in generic names:

A. Different situation in India:

Although increasing trend of generic prescriptions is bringing down the overall cost of healthcare in general and for medicines in particular elsewhere in the world, the situation is quite different in India.

In India over 99 percent of over US$ 13 billion domestic pharmaceutical market constitutes predominantly of branded generics and some generic medicines without brand names.

B. Allegation of branded generic prescriptions linked with marketing malpractices:

As Reuters reported, quoting public health experts and some Indian doctors, that due to an unholy nexus between some pharmaceutical companies and a large section of the medical profession, drugs are not only dangerously overprescribed, but mostly expensive branded generics are prescribed to patients, instead of cheaper equivalents. The reports said that this situation can be ‘devastating for patients — physically and financially — in a country where health care is mostly private, out of pocket, unsubsidized and 400 million people live on less than US$ 1.25 a day’.

It is now a matter of raging debate that many branded generic prescriptions are closely linked with marketing malpractices.

Not just the media and for that matter even a Parliamentary Standing Committee in one of its reports highlighted, bribing doctors by many pharma players in various forms and garbs to prescribe their respective brand of generic drugs has now reached an alarming proportion in India, jeopardizing patients’ interest seriously, more than ever before and  observed that speedy remedial measures are of utmost importance.

C. MCI initiative on prescription in generic names: 

To address this major issue the Medical Council of India (MCI) in its circular dated January 21, 2013 addressed to the Dean/Principals of all the Medical Colleges, 
Director of all the hospitals and the
 Presidents of all the State Medical Councils directed as follows:

“The Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulations, 2002 inter-alia prescribes as under regarding use of generic names of drugs vide clause 1.5.

1.5 – Use of Generic names of drugs: Every physician should, as far as possible, prescribe drugs with generic names and he/she shall ensure that there is a rational prescription and use of drugs.”

All the Registered Medical Practitioners under the IMC Act are directed to comply with the aforesaid provisions of the Regulations without fail.

You are requested to give wide publicity of the above regulation to ensure that all the doctors practicing medicine under your jurisdiction comply with the regulation.”

MCI also urged the Medical profession to implement the above provision for prescriptions in generic names both in its letter and spirit.

As the situation has not changed much just yet, it is up to the MCI now to enforce this regulation exactly the way as it has intended to. Otherwise the value of this circular will not even be worth the paper on which it was printed by this august regulatory body.

D. Parliamentary Standing Committee recommends it:

As mentioned above, prior to this circular, Parliamentary Standing Committee (PSC) for Health and Family Welfare in its recommendation to the ‘Rajya Sabha’ of the Indian Parliament on August 4, 2010, also recommended prescription of medicines by their generic names.

E. Why is the bogey of ‘product quality’ so active only for generic prescriptions and not for branded generics?

It is indeed difficult to fathom why is the product quality issue, which could make drugs unsafe for the patients, being raised so much for generic medicines without a brand name and not for branded generics?

The following questions should well be raised for greater clarity on the quality issue with generic medicines without a brand name, for all concerned:

  • Are all generic medicines of dubious quality and branded generics are of good quality?
  • If quality parameters can be doubted for both branded generics and generics without a brand name, in many cases, why then raise this issue only in context of prescribing generic medicines ?
  • If quality issues are not much with the larger companies and are restricted to only smaller companies, why then some branded generic drugs of smaller companies are being prescribed so much by the doctors?
  • Currently many large companies market the same drugs both as generics without a brand name and also as branded generics, why then the branded generic versions are prescribed more than their generic equivalents, though manufactured by the same large companies having the same quality profile?
  • Why are the generic medicines of good quality available at ‘Jan Aushadhi’ outlets (though small in number) cost a fraction of their branded generic equivalents and not being prescribed by most of the doctors?
  • Why do the doctors not show much interest in prescribing generic medicines as of date and defend the branded generics on the same ‘quality’ platform?
  • Why not those who argue that phonetically similar or wrong reading of generic names at the chemist outlets may cause health safety hazard to the patients, also realize that many already existing phonetically similar brand names in totally different therapy areas may cause similar hazards too?
  • How does a doctor while prescribing a branded generic or generic medicine pre-judge which ones are of good quality and which others are not?

These questions, though may be uncomfortable to many, nevertheless merit clear, unambiguous, straight and specific answers.

3. In case MCI directive does not work – Government initiative on ‘Patient Empowerment’:

A. Laudable Government initiative:

Recognizing this issue in tandem, on December 7, 2012 the Department of Pharmaceuticals together with the National Pharmaceutical Pricing Authority announced as follows:

“There are number of drugs available in the market with same medicament composition with wide variation in their prices.  The prescription of doctors also varies from low price to high priced drugs for the same ailment. Government of India intends to launch an SMS based patient awareness scheme, which would enable the patients to know the cheaper alternatives medicines available”.

The timeline for implementation of this initiative was announced as six month from the date of awarding the contract.

It was reported that in this mobile phone based program, consumers by sending a text message of any branded generic drug prescribed by the doctors would get an SMS reply with a list of brands of the same molecule along with their prices to exercise their choice of purchase.

As usually happens with most government decisions, the gestation period of this laudable ‘patient empowerment’ initiative perhaps will get over not before end 2013.

B. One interesting private initiative:

One interesting private websites that I have recently come across offering information on branded generic drugs is www.mydawaai.com (I have quoted this website just to cite an example and not to recommend or promote it in any form or manner). There may be other such websites, as well, in the cyberspace.

However, in this website, if anyone types the brand name of the drug that one is looking for, the following details will be available:

  1. The generic version of branded medicine.
  2. The company manufacturing the brand.
  3. Its estimated cost in India
  4. Alternative brand names with same generic salt.
  5. The cost effectiveness for different brand for the same salt.

Such information, if available easily from the Government or any highly credible source, will indeed help patients having access to affordable low cost medicines to lessen their out of pocket financial burden, at least for medicines.

Conclusion:

In India, even if branded generic prescriptions continue despite MCI directive, to empower patients making an informed choice to buy low priced formulations of the same prescribed molecule, the above ‘Patient Empowerment’ initiative will play a very critical role.

Thus, I reckon, to improve access to affordable medicines in India, like many other countries elsewhere in the world, the above small steps that are being taken by the MCI, the Department of Pharmaceuticals, the National Pharmaceutical Pricing Authority and other private players are indeed laudable and must be encouraged.

Kudos will pour in, from India and abroad, if such small and simple steps get ultimately translated into a giant leap in the healthcare space of the country…for patients’ sake.

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.

‘Free Essential Medicines for All’ – A Laudable Public Healthcare Initiative of India, Tough Challenges Notwithstanding

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Recently the Government of India has taken a landmark ‘Public Healthcare’ related initiative to provide unbranded generic formulations of all essential drugs, featuring in the ‘National List of Essential Medicines 2011’, free of cost to all patients from the public hospitals and dispensaries, across the country.

This social sector project is expected to roll out, as reported in the media, from October/November this year with a cost of around US$ 5 billion during the 12th Five Year Plan period of the country.

Considering medicines account for around 70% of the total ‘Out of Pocket’ expenses, this particular initiative is expected to benefit, especially the poorer patients, significantly.

Recommendations of the Parliamentary Standing Committee:

Noting the keen interest of the Government for speedier implementation of this scheme, it appears that the Ministry of Health has accepted the recommendations made by the ‘Parliamentary Standing Committee (PSC) for Health and Family Welfare’ to the Indian Parliament on August 4, 2010, regarding prescription of medicines by their generic names in the Public hospitals and dispensaries, to start with.

In this context, it is worth noting that the ‘Drugs Technical Advisory Board (DTAB)’ has also reportedly considered the proposal to amend the rules of the ‘Drugs and Cosmetics Act of India’ for regulatory approval of all drug formulations containing single active ingredient in the generic names by all State Licensing Authorities.

This recommendation of the  PSC is based on the premises that the ‘Brand Building’ exercise of the generic drugs includes a very high sales and marketing expenditure.

The Committee felt that by putting in place a well structured policy such ‘avoidable’ expenditures can easily be eliminated making generic medicines available to the common man at much cheaper prices. ‘Jan Aushadhi’ scheme of the Government is often cited as an example to drive home this point.

The scheme is new for India, but other countries have already taken similar steps:

Just to cite an example, as reported by ‘The Guardian” on August 23, 2011, the Spanish government recently enacted a law compelling the doctors in Spain to prescribe generic drugs instead of more expensive patented and branded pharmaceuticals, wherever available. This move is expected to help the Spanish government to save €2.4 billion (£2.1billion) a year, as in Spain the drug costs are partly reimbursed by the government.

As a result, the doctors in Spain require prescribing only in the generic or chemical names of such drugs. Consequently the pharmacies will be obliged to dispense ‘the cheapest available versions of drugs, which will frequently mean not the better-known brand names sold by the big drugs firms’.

Product quality of generic/ generics and branded generics:

Drugs and Cosmetics Act of India requires all generic/generic and branded generic drugs to have the same quality and performance standards. Thus when a generic/generic medicine is approved by the drug regulator, one should logically expect that it has met with the required standards set for the identity, strength, quality, purity and potency of the chemical substance.

It is not uncommon that there could be some variability taking place during their manufacturing process and all formulations of both the categories produced by different manufacturers may not also contain exactly the same inactive ingredients.

In any case, both generic/generic and branded generic drugs must be shown to be bio-equivalent to the reference drugs with similar blood levels to the respective reference products. Regulators even in the USA believe that if blood levels are the same, the therapeutic effect will also be the same.

A recent study:

As reported by the US FDA, “A recent study evaluated the results of 38 published clinical trials that compared cardiovascular generic drugs to their brand-name counterparts. There was no evidence that brand-name heart drugs worked any better than generic heart drugs. [Kesselheim et al. Clinical equivalence of generic and brand-name drugs used in cardiovascular disease: a systematic review and meta-analysis. JAMA. 2008;300(21)2514-2526]”.

Generic drugs are prescribed more, even in America:

As per published reports, generic medicines account for around 78% of the total prescriptions dispensed by retail chemists and long-term care facilities in the US. For example, in 2010 generic prescriptions were four percentage points more than what these were in 2009 and came up from 63% as recorded in 2006.

Capacity constraints could hold back full implementation of the Indian initiative:

Huge shortages in the number doctors, nurses, paramedics and hospital beds per 10,000 population in India will pose a tough challenge for speedier implementation of ‘Free medicines for all’ project in the country. India should respond to its healthcare infrastructure developmental needs much faster now than ever before to achieve its objective of providing ‘healthcare to all’, sooner.

Overall impact of the scheme:

I reckon, this new scheme will hasten the overall growth of the pharmaceutical industry, as poor patients who could not afford will now have access to essential medicines. On the other hand, rapidly growing middle class population will continue to favor branded generic drugs prescribed by the doctors at the private hospitals and clinics.

Some people are apprehending that generic drug makers will have brighter days as the project starts rolling on. This apprehension is based on the assumption that large branded generic players will be unable to take part in this big ticket drug procurement process of the Government.

However, in my view, it could well be a win-win situation for all types of players in the industry, where both the generic/generic and branded generic businesses will continue to grow simultaneously, because of the reasons as mentioned above.

That said procedural delays and drug quality issues while procuring cheaper generics may pose to be a great challenge for the Government to ensure speedier implementation of this project. Drug regulatory and law enforcing authorities will require to be extremely vigilant to ensure that while sourcing cheaper generic drugs, “Public health and safety” due to quality issues do not get compromised in any way.

How long will it take?

Full implementation of ‘Universal healthcare’ projects takes considerable time in any country. China has taken a long time for its roll-out covering even a larger population than India. Even Mexico has reportedly taken more than seven years for implementation of similar public healthcare initiative.

Thus, I guess, though it is quite possible for India to offer ‘Free Essential Medicines’ to its 1.13 billion people, it may take a decade long efforts for the country to reach out to the entire population.

Are generic/generic drugs really cheaper than their branded generic equivalents?

The recommendation of the ‘Parliamentary Standing Committee for Health and Family Welfare’ on this issue, as stated above, makes sense for India. However, the moot question, which is the basis of choosing generic/generic drugs over their branded generic equivalents, still remains as follows:

“Are the generic/generic drugs really cheaper than their branded generic equivalents in India?”

From the MRPs, as printed on the packs of both branded generic and the generic/generic formulations, it appears that this basic assumption may not hold good universally across the country.

Following examples will vindicate this point:

Molecule

Product

Company

Batch No.

Price Per Tab.
Telmisartan 40 mg Branded Generic

Telmiline 40 mg

John SmithKline

M111622

14/-
Generic/Generic

Generic

Unichem

BTL(11/11001)

30/-

 

Molecule

Brand/ Generic

Company

Batch No.

Price Per Tab.
Rosuvastatin 10 mg Branded Generic

Rosufine

Morpen

P20472

13.20
Generic/Generic

Generic

Sharon Bio-Medicines

AC-2159

16/-

 

Molecule

Brand/ Generic

Company

Batch No.

Price Per Tab.
Cetirizine HCL 10 mg Branded Generic

Cetfast

Elder

CO81810

2.50
Generic/Generic

Generic

Ra Biotech

CT 016B

3/-

 

Molecule

Brand/ Generic

Company

Batch No.

Price Per Tab.
Nimesulide 100 mg Branded Generic

NICIP

Cipla

-

2.53
Generic/Generic

Generic

Themis

-

3/-

 

Molecule

Brand/ Generic

Company

Batch No.

Price Per Tab.
Amlodipine 5 mg Branded Generic

Aginal 5

Alkem

-

2.48
Generic/Generic

Generic

Sandoz

-

2.70

 

Molecule

Brand/ Generic

Company

Batch No.

Price Per Tab.
Ampicillin 500 Branded Generic

Ampisyn

Cipla

-

6.40
Generic/Generic

Generic

SGS

-

7.50

As on July 6, 2012

Let me hasten to add, it is quite possible to present another set of examples, which may show that the MRPs of generic/generic drugs are lesser than the comparable branded generics.

However, the bottom-line is, it will not be fair to comment that MRPs of generic/generic drugs, which do not include any expenditure towards ‘brand-building’, are always significantly lesser than their branded generic counterparts as shown above.

Why are MRPs of generic/generics and branded generics not much different?

It is a general perception, as stated above, that ‘Brand Building’ exercise for generic drugs in India includes a very high component of ‘sales and marketing expenditures’ which are built into the price, making MRPs of the branded generic formulations significantly higher than their generic/generic equivalents.

However, it will not be realistic to accept that generic/generic drugs are not promoted at all, in any form, by the concerned manufacturers. The fact is, in case of generic/generic medicines almost the same amount that is spent on ‘sales and marketing’ for branded generic drugs, is passed on to the retail chemists by their manufacturers as huge incentives for promotion and substitution of such drugs by the respective pharmacies.

Thus, in a large number of cases the patients do not get any significant pricing benefit for buying generic/generic drugs against doctors’ prescriptions instead of branded generics from the retail outlets. 

Conclusion:

In the prevailing scenario, the decision of the Government to procure and distribute only the generic/generic essential medicines through public hospitals/dispensaries simply on pricing ground, keeping the branded generics at bay, is indeed intriguing.

From the data presented above, it will be quite reasonable to believe that MRPs being similar, the ‘sales and marketing’ costs for branded generics are quite comparable to hefty discounts being passed on to the wholesalers and retail chemists by the manufacturers of generic/generic drugs.

Hence, in the balance of probability, a branded generic product can well compete with its genuine generic/generic equivalent, even on pricing ground, in the government procurement process.

Thus, to be fair to the pharmaceutical companies, across the board, the government should invite all generic manufacturers selling their products with or without brand names to participate in the public procurement process and thereafter make the final purchase decisions based on well laid out and transparent criteria, which can stand scrutiny of the strictest audit. 

That said, I fully recognize that the participation in the public procurement process of essential medicines, will indeed be the business decision of individual  companies. If it makes commercial sense, there is no reason why large companies, including the multinationals, will not participate in this laudable project of the Government.

The record of the Government in the implementation of various social sector projects, thus far, may not be brilliant by any measure. Despite that, it does make enough sense for all of us to be rather optimistic about this well hyped ‘Free Essential Medicines for all’ project of India, considering the immense benefits that the common man will derive out of it.

For the effective implementation of the project, the government should now get adequately prepared with required wherewithal, put in place world class skill-sets by partnering with private domain experts wherever required and chart the pathway of success with clearly assigned accountability to each individual responsible for translating this grand ‘Public Healthcare’ initiative of India into reality .

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.

State funded ‘Universal Healthcare’ in India: A laudable initiative of the Government

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January 11, 2011 edition of ‘The Lancet’, in the article authored by Prof. K. Srinath Reddy et al titled, “Towards achievement of universal health care in India by 2020: a call to action”, proposed creation of an Integrated National Health System in India through provision of universal health insurance, establishment of autonomous organizations to enable accountable and evidence-based good-quality health-care practices and at the same time reduce the high out-of-pocket expenditure on health care through a well regulated integration of the private sector within the national health-care system of India, by 2020.

About six months later, in its August 16, 2011 issue ‘The Times of India’ reported that the Planning Commission of India is currently framing up the blue print for a universal health insurance scheme which would provide a minimum cover to everyone in the country. It is expected that a surcharge will be levied for this Universal Health Care (UHC) initiative.

Though UHC is indeed a very commendably initiative for India as a nation,  some dubious and self-styled ‘healthcare crusaders’ have already started raising the bogey of ‘the inadequacy’ of the scheme as a diversionary measure to misguide the easily vulnerable common man of the country.

Efforts being made to sensationalize the current status of the Indian healthcare system:

Even in the backdrop of UHC initiative, the following sensational headlines could be fallacious at times, which more often than not are being misused by the vested interests:

  • “About 1.8 million children under age of 5 die in India every year; 68,000 mothers die due to maternal causes, and 52 million children in the country are stunted”.
  • “With 70% people living in more than 600,000 villages across rural India, not more than an estimated 30% have access to modern medicine”.

It is unfortunate that many key stakeholders, interested in improved healthcare system, are continuously engaged in an eternal blame game of ‘it is not my monkey’. At the same time, taking advantage of this confused situation, some other groups plan to facilitate their vested interests by projecting a ‘weaker India’ with contentious planted reports both overtly and covertly.

In this prevailing scenario, which has been continuing since the last several decades, there is no dearth of people who would attempt to hijack the health interest of the nation to harvest mega commercial benefits.

While all concerned should keep a vigil on such sinister design, let me now try to place some hard facts before you on the current healthcare scenario in India in the context of UHC.

The facts on access to ‘round the year’ healthcare facilities in India:

As reported by the Government of India in 2004, access to healthcare infrastructure and services for the rural villages in terms of percentages were as follows (Source: India Health Report 2010) :

  1. Primary Health Centers:  68.3
  2. Sub-Centers:   43.2
  3. Government Dispensaries:  67.9
  4. Government hospitals in urban areas:  79
  5. Private Clinics:  62.7
  6. Private Hospitals:  76.7

I reckon, after implementation of National Rural Health Mission (NRHM) and National Urban Health Mission (NRUM), this situation prevailing in 2004 has improved. However, the scope for further improvement in all these areas still remains very high. UHC could be a key facilitator.

In any case, the shrill voice highlighting around 65% of population of India does not have access to healthcare or medicines seem to be highly misplaced.

‘Access to Modern Medicines’ is improving in India, slowly but surely:

Contrary to the above propaganda, in the real life situation the access to modern medicines by the common man in the country even in the rural India is steadily increasing.

This is evidenced by the facts, CAGR (volume) of the pharmaceutical industry since the last ten years has been around 13%, leaving aside another robust growth factor being contributed through the introduction of newer brands, 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.

IPM maintained a scorching pace of 16.5% growth in 2010. A recent forecast of IMS highlights near similar growth trend in 2011, as well.

In addition, extension of focus of the Indian pharmaceutical Industry, in general, to the fast growing rural markets, which are currently growing at a much faster pace than ever before, clearly supports the argument of increasing ‘Access to Modern Medicines’ even in rural India. The improvement 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 modern medicines in India.

For arguments sake, out of this rapid growth of the IPM, year after year consistently, if I attribute just 5% growth per year, for even the last nine years over the base year of 1998 (as reported in 2004 by WHO) to improved access to medicines, it will indicate, at least, 57% of the population of India currently has access to modern medicines and NOT just 35%, as I wrote in my blog earlier, quoting the numbers from the above WHO report of 2004.

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 prefer to live on to our past.

Be that as it may, around 43% of the population will perhaps still not have ‘Access to Modern Medicines’ in India. This issue needs immediate attention of the policy makers and can be resolved with a holistic approach. UHC initiative together with improvement of healthcare infrastructure and delivery systems are the needs of the hour.

So called ‘Diseases of the Poor’ are no longer the ‘Leading Causes of Death’ in India:

As stated above, the disproportionate diversionary focus on the diseases of the poor by the vested interests, being the leading causes of death in India, should be re-validated with the data available with the office of the Registrar General of India (2009). This report highlights a totally different scenario, where the top five leading causes of death in terms of percentage, have been reported as follows:

  1. Cardiovascular diseases:  24.8
  2. Chronic Obstructive Pulmonary Disease (COPD): 10.2
  3. Tuberculosis: 10.1
  4. Cancer: 9.4
  5. Ill-defined conditions: 5.3

Thus the diseases of the developed world, like cardiovascular diseases, COPD and Cancer cause over 45% of the total deaths in India, whereas Tuberculosis, Malaria, Diarrhea and digestive diseases cause around 23% deaths in the country. I reckon, UHC will take care of this emerging disease pattern in India.

The key reasons for not seeking medical treatment are not always poor ‘Access to Healthcare’:

While promoting the UHC, the government should take note of the key reasons for not seeking medical treatment, across socioeconomic milieu in the country. These reasons are not predominantly due to ‘Poor Access to Healthcare ‘. The following data will vindicate this point:

Reason

Rural Poorest 20%

Rural Richest 20%

Urban Poorest 20%

Urban Richest 20%
Financial Reasons

39.7

21.2

37.2

2.3
Ailments not considered serious

27.2

45.6

44.3

84.4
No Medical facilities

12.8

10.0

1.6

_
Others

20.3

23.2

16.9

13.3

Total

100

100

100

100

(Source: India Health Report 2010)

All these are happening probably because we do not have, as yet, any ‘well-structured healthcare financing system’ for all section of the society. The UHC initiative could well be a very significant part to the solution of this long standing problem together with other specific important measures, some of which I have already deliberated above.

While addressing the healthcare financing issue of India, January 11, 2011 edition of ‘The Lancet’ in its article titled, “Financing health care for all: challenges and opportunities” commented:

“India’s health financing system is a cause of and an exacerbating factor in the challenges of health inequity, inadequate availability and reach, unequal access, and poor-quality and costly health-care services. The Government of India has made a commitment to increase public spending on health from less than 1% to 3% of the gross domestic product during the next few years…. Enhanced public spending can be used to introduce universal medical insurance that can help to substantially reduce the burden of private out-of-pocket expenditures on health.”

I reiterate in this context, UHC initiative brings a breadth of fresh air to the prevailing rather gloomy healthcare financing scenario in India.

A comparison of private (out of pocket) health expenditure:

Look at it from, any angle, the general population of India is most burdened with high’ out of pocket healthcare expenses’ compared to even all of our neighboring countries:

1. Pakistan: 82.5% 2. India: 78% 3. China: 61% 4. Sri Lanka: 53% 5. Thailand: 31% 6. Bhutan: 29% 7. Maldives: 14%

(Source: The Lancet)

This factor itself, in case of just one or couple of serious illnesses, could make a middle class household of India poor and a poor could be pushed even Below the Poverty Line (BPL). UHC initiative of the Government is expected to change this scenario significantly in the years ahead.

The key unresolved issue of ‘affordability’ will get partially unresolved with UHC:

The above edition of ‘The Lancet’ highlighted that outpatient (non-hospitalization) expenses in India is around 74% of the total health expenses and the drugs account for 72% of this total outpatient expenditure. The study has also pointed out that 47% and 31% hospitalization in rural and urban areas respectively, are financed by loans and sell off assets.

This critical issue of ‘affordability’ of modern medicines is expected to get, at least partially resolved with the UHC scheme of the Government.

Around 32% of Indian BPL population can’t afford to spend on medicines:

While framing the UHC scheme, the government should keep in mind that a population of around 32% in India, still lives below the poverty line (BPL) and will not be able to afford any expenditure, however minor it may be, towards medicines. Proper implementation of the RSBY scheme with military precision, will be the right approach to this marginalized section of the society.

National Health Entitlement Card:

According to the Planning Commission, to enable the citizens availing the facilities provided by the ‘Universal Healthcare,’ the government will issue a ‘National Health Entitlement Card’, which will guarantee free access to  relevant healthcare packages designed for the primary, secondary and tertiary healthcare for all. This scheme will be fully funded by the Central Government and cover both inpatient and outpatient services.

Conclusion:

Thus in the current scenario, the initiative of ‘Universal healthcare’ to provide access to healthcare to all citizens of India by addressing the critical issue of high incidence of ‘out of pocket’ expenses towards health care, is indeed a laudable initiative and ushers in a breadth of fresh air, despite all motivated comments against it.

We need also to keep in mind, although the ‘Universal healthcare’ is a fascinating mega initiative by the Planning Commission of India, this may not resolve all health related maladies of the country in one stroke.

Even in the changed scenario, a large section of the population both rich and poor and from both urban as well as rural India, may continue to not seek medical treatment assuming initially many of their ailments are not serious enough. Such a situation will definitely not materially improve the healthcare scenario of India, quite adversely affecting the economic progress of the country.

Such a situation, if continues, will necessitate continuous disease awareness campaigns with active participation of all stakeholders, including the civil society across the country, sooner than later, in tandem with all other measures as may deem necessary from time to time.

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 First Pharmaceuticals Census of India – a commendable initiative by the National Pharmaceutical Pricing Authority (NPPA)

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Currently there is indeed a crying need for the pharmaceutical industry to generate a robust data base to formulate not only various healthcare related policies, but also to measure the level of their effective implementation. In the absence of such dependable and credible facts, most of the arguments, which take place between the government and other stakeholders, are mainly based on ‘your views’ versus ‘our views’.

An admirable initiative:

To address this critical need, more than a couple of years ago in February 2008, the National Pharmaceutical Pricing Authority (NPPA) announced their intent to initiate the first pharmaceuticals census of India (FPCI). The main purpose of this census is to create a structured, comprehensive and dependable pharmaceutical industry related database in the country to capture valuable information, which could be prudently used by the government towards effective planning, policy making and good governance. NPPA is also expected to publish this census data for all stakeholders and other ministries within the government for appropriate actions.

Create a ‘Common Thread’:

This ‘Pharmaceutical Map’, I guess, will be able to create a common thread for the Ministry of Health, Departments of Pharmaceuticals and Biotechnology, Ministry of Commerce & Industries and the Ministry of Finance based on which each of them will frame their respective healthcare related policies targeting the needs of a vast majority of the population of the country, for inclusive growth.

The ‘Methodology’ will be very important:

I understand that the FPCI is expected to cover over 10,000 manufacturing units in the country in a well-structured manner to produce an elaborate healthcare related credible data bank for India. The methodology that will be followed for this census will determine the credibility of the data thus generated.

My expectation from the FPCI is that, as announced, this will be able to provide credible details, among others, on the following ten key areas of the Pharmaceutical Manufacturing Units (PMUs) to enable the policy makers to frame policies based on the ground realities and at the same time measure the level of their effective implementations:

• Turnover by types and class (Micro, Small, Medium, and Large)
• Locations with separate details of Export Oriented Units (EOUs)
• Capacity installed, capacity utilized by major products
• Number of ‘own’ and ‘loan’ licenses units and by type of units, license issued by the respective state
drug controllers
• Types, class and pattern (plant & machinery, land & building) of investments
• Consumption of indigenous and imported inputs and utilities
• Adherence to GMP
• Product types and pricing
• Pattern of expenditure on R&D, clinical trials and quality control
• Employment generated in the country by the pharma sector

All these data will be available state-wise and district-wise by class and types of industry (API, formulations), among others.

It has been reported that NPPA has by now progressed quite a lot with the FPCI and the Final Report may be published soon.

Conclusion:

It would have been excellent, if FPCI would also have generated data on ‘Access to Modern Medicines’ in India.

Be that as it may, this is an admirable initiative by the NPPA. Data thus generated will be immensely useful to all stakeholders, if updated in every 3 to 5 years to maintain their relevance.

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.

Open Source Drug Discovery (OSDD) initiative for the tropical diseases by CSIR and cancer by GlaxoSmithKline deserves a big applaud and support from all concerned.

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As the name suggest the ‘Open Source Drug Discovery (OSDD)’ is an open source code model of discovering a New Chemical Entity (NCE) or a New Molecular Entity (NME). In this model all data generated related to the discovery research will be available in the open for collaborative research inputs. The licensing arrangement of OSDD where both invention and copyrights will be involved, are quite different from any ‘Open Source’ license for a software development.

In OSDD, the key component is the supportive pathway of its information network, which is driven by three key parameters of open development, open access and open source.

The Objectives of OSDD:

The key objective of OSDD is to encourage drug discovery initiatives, especially for the neglected diseases of the world to make these drugs affordable to the marginalized people, especially of the developing world.

International initiative:

In June 2008, GlaxoSmithKline (GSK) announced in Philadelphia, “It was donating an important slice of its research on cancer cells to the cancer research community to boost the collaborative battle against this disease.”

With this announcement genomic profiling data for over 300 sets of cancer cell lines was released by GSK to the National Cancer Institute’s bioinformatics grid. It has been reported that around 1000 researchers actively contribute to this grid from across the industry, research institutes, academia and NGOs.

Many believe that the OSDD initiative will gain momentum to encourage many more academic institutions, researchers and even smaller companies to add speed to the drug discovery process and at the same time make the NCEs/NMEs coming through such process much less expensive and affordable to a large section of the society.

On an average it takes about 8 to 10 years to bring an NCE/NME to market with a cost of around U.S$ 1.7 billion.

OSDD in India:

In India, Dr. Samir Brahmachari, the Director General of the Council of Scientific and Industrial Research (CSIR) is the champion of the OSDD movement. CSIR believes that for a developing country like India, OSDD will help the common man to meet his unmet medical needs in the areas of neglected tropical diseases.

OSDD in India is a global platform to address the neglected tropical diseases like, tuberculosis, malaria, leishmaniasis by the best research brains of the world, together.

To fund the OSDD initiative of the CSIR the Government of India has allocated around U.S $40 million and an equivalent amount of funding would be raised from international agencies and philanthropists.

It has been reported that current priority of CSIR in its OSDD program is the tuberculosis disease area.

Why tuberculosis?

The published reports indicate, in every 1.5 minutes one person in India dies of tuberculosis and about 33 percent of the global population is infected primarily with Mycobacterium tuberculosis. The world is still quite far from having an effective vaccine or drug, which can offer long term protection against this dreaded disease.

Partnerships of Industry with belief in Open Source systems and models with CSIR in its OSDD project for tuberculosis, could help finding out a suitable answer to this long standing problem, sooner than later.

Success of OSDD initiative of CSIR:

Late November 2009, I received a communication from the CSIR informing that their OSDD project, since its launch in September 2009, has crossed 2000 registered users. The pace of increase in the number of registered users indeed reflects the confidence this initiative has generated among the interested researchers, the world over.

OSDD community of CSIR has several credits to be proud of including open peer review, open funding review, large number of real time data on open lab notebook.

CSIR has also indicated that the next big leap planned by them is to completely re-annotate the MTb genome for which OSDD has launched ‘Connect to Decode’ 2010 (http://crdd.osdd.net). They initially expected about 150 participants to join, but within a week, they got about 450 participants. That is really the strength of collaboration on OSDD!

Congratulations CSIR and its leader Dr. Samir Brahmachari.

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.

National Rural Health Mission (NRHM), a much hyped public healthcare initiative – has it delivered since its inception in 2005?

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National Rural Health Mission (NRHM), a very ambitious and noble initiative for the rural population of India was launched by the Government of India on April 12, 2005. The interim budget allocation of NRHM for the year 2009–10 has been increased to Rs. 12,070 crore. The primary purpose of NRHM, as announced by the Government, was to improve access to quality healthcare for the poor population of 18 states, to start with, of rural India.

Along with such a commendable initiative, the Government declared an increase in its spending towards public health from mere 0.9% to 2–3% of the GDP over a five year period. This decision was in line with the well articulated prime focus of the Government on public health and education.

During the launch of NRHM, the Health Minister of India announced that the nation would see the results of these efforts in three years time.

Three years are over now. Let us, therefore, have a look at the key achievement areas of this ambitious scheme for the budget year 2008-09, as announced by the Finance Minister recently in his interim budget speech for 2009–10.

The performance areas were highlighted as follows:

• 462,000 Associated Social Health Activists were trained
• 177,924 villages have sanitation committees functional
• 323 district hospitals have been taken for up gradation

Against such a soft performance parameters of the Government, let us see some hard facts, which are real indicators of performance of NRHM. A report on the recent study done by Chronic Care Foundation indicates that in India about 86% of highly populated rural districts still do not have provisions for basic diagnostic tests for chronic ailments.

The study also highlights that in rural areas, as a percentage of total expenses, out of pocket healthcare costs are more than the urban areas, with hospitalization expenses contributing the most to the total costs. In many rural areas the healthcare costs have been reported to be as high as around 80% of the total expenses. Such a high out of pocket expenses have mainly been attributed to the lack of facilities in these rural areas, requiring patients to travel to distant areas for medical treatment. It was also reported that even in rural areas due to inefficient and inadequate services at the Government healthcare units, there has been a very high dependence on more expensive private healthcare facilities.

After almost four years from the inception of NRHM, if this is the state of affairs for rural public healthcare, the obvious questions which come to my mind are as follows:

• Where is the huge money allocated for NRHM going?
• Who is or are accountable for such a poor performance of this great scheme?

In my opinion, to make NRHM work satisfactorily the Government should outline, decide and announce the key success parameters for performance evaluation of the scheme. This is to be done disclosing the names and designations of the responsible senior Government officials who will be held accountable for the success or failure to deliver the deliverables. All these details should be uploaded on to the website of the Ministry of Health for public scrutiny, at least half yearly. With tax-payers money being utilised for this important and critical public health arena, no non-performance should escape attention and go unpunished.

Moreover, with the help of experts, the Government should decide, which elements of each identified success parameters the Government will be able to deliver better with its own internal resources and which are those areas where the Government should outsource.

Such an approach when worked out in great details will be able to ensure whether through NHRM the country is making progress to improve access to quality healthcare for a vast majority of its rural population. Otherwise this scheme may well be treated just as one of those which failed to deliver and vanished in the oblivion.

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.