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Non-Communicable Diseases (NCD) are hitting the poor even harder, economically: a time to ponder and a time to act

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November 11, 2010 edition of ‘The Lancet’ published an article titled, “Raising the priority of preventing chronic diseases: a political process”. The article enumerated the following:

“Chronic diseases, especially cardiovascular diseases, diabetes, cancer, and chronic obstructive respiratory diseases, are neglected globally despite growing awareness of the serious burden that they cause. Global and national policies have failed to stop, and in many cases have contributed to, the chronic disease pandemic. Low-cost and highly effective solutions for the prevention of chronic diseases are readily available; the failure to respond is now a political, rather than a technical issue.”

The situation is no different in India. The disease pattern in India is also showing a perceptible shift from age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23 percent in 2005 to 26 percent in 2009. It has been estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade.

As a consequence of such findings healthcare needs and systems of the country should need to undergo a paradigm shift with the emergence of a carefully planned concept of ‘Preventive Healthcare’ in the country.

It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:
There is a common perception that non-communicable diseases are more prevalent within higher socio-economic strata of the society, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

Current healthcare system in India:

Currently the medical alleviation of the acute symptoms and the disease that a particular patient is suffering from is the key concern of all concerned starting from the doctor to the patient and his/her family. The process of the medical treatment revolves round symptom relief, diagnostic measures and appropriate treatment protocols and procedures conforming to the proper diagnosis of the ailments. While addressing the acute problems of the patients’ ailments is very important, proper assessment of the underlying diseases or evaluation of their risk factors do not get as much or no attention. As a result the important advice on preventive healthcare from the doctor properly highlighting its importance is not available to most of the patients.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become the crying need of the hour.

‘Preventive Healthcare’ in India should be made mandatory:

The ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn help the population to remain disease free and thereby to improve their respective work productivity in a very significant way.

Taking all these points into consideration, through policy initiative, The Medical Council of India (MCI) should make ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor through appropriate regulations.

Chronic illnesses will significantly increase the disease burden of the country:

Many of the diseases like cancer, chronic respiratory disorders, cardiovascular, diabetes can be identified with preventable risk factors and. Therefore, such diseases can be prevented effectively, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation.

Role of a medical professional in customized ‘disease prevention plan’:

Role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advice the patients about the ways of specific disease prevention, for which the individual patients have high exposure.

Need to raise general public and political awareness towards ‘Preventive Healthcare’:

Raising the level of awareness for ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general together with healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the Planning Commission, the government of India has reported to have initiated structured measures for the prevention of NCD, the main features of which are as follows:

• “Health education for primary and secondary prevention of NCDs through mobilizing community action
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction
• Development and support of institutions for the rehabilitation of people with disabilities
• Research support for: Multispectral population-based interventions to reduce risk factors
• The role of nutrition and lifestyle-related factors
• The development of cost effective interventions at each level of care”

Conclusion:

Many diseases in India with proper ‘Disease Prevention’ measures can be effectively averted. Some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

To address this issue ‘The Lancet’ November 11, 2010, in the article, as mentioned above, prescribed three specific strategies as follows:

1. “Reframe the debate to emphasize the societal determinants of disease and the inter-relation between chronic disease, poverty, and development
2. Mobilize resources through a cooperative and inclusive approach to development and by equitably distributing resources on the basis of avoidable mortality
3. Build on emerging strategic and political opportunities, such as the World Health Assembly 2008—13 Action Plan and the high-level meeting of the UN General Assembly in 2011 on chronic disease”.

The government should spearhead the paradigm shift towards this direction with appropriate regulation, generating increased societal and political awareness within the country and through mobilization of adequate resources. All these will ultimately help us to translate the well-known dictum into reality, ‘prevention is better than cure’.

Otherwise, especially the poorer section of the society will continue to get caught in the vicious cycle of debt and illness, seriously jeopardizing the economic progress of the country.

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 importance of ‘Supply Chain Integrity’ in ‘Global Supply Chain Management (GSCM)’ process

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Since the last decade with increasing pace of change, mostly in the western world has accelerated the globalization process in the Pharmaceutical Industry across the world. The key drivers to these changes are as follows:

1. A large number of patent expiration hugely impacting the top-line growth
2. Research pipeline is drying-up
3. The cost of bringing a new molecule from ‘the mind to market’ has now touched around US $ 1.75 billion
4. Regulatory requirement to get the marketing approval is getting more and more stringent, basically for patients’ safety, making clinical development more expensive and time consuming
5. Cost containment measures of various governments around the world is putting an immense pressure on product price, significantly affecting the profit margin

Changing Business Process:

All these factors are triggering other sets of consequential strategic events of enormous significance. Among those, following key corporate strategic steps indeed stand out:

1. More mergers and acquisitions of various size and scale to achieve both revenue and cost synergy, with new products and newer types of resources

2. Transformation in the fundamental operating models, e.g. R&D focused companies like Pfizer, GSK, sanofi aventis are extending their business interest in the pharmaceutical generics space, as well

3. Increasing globalization process and more focus on the emerging markets of the world like, Brazil, Russia, India, China, Turkey, Mexico

4. Growing emphasis on partnering, as we see in India, like for example, between Pfizer and Aurobindo, Claris and Biocon, GSK with Dr. Reddy’s Lab (DRL), AstraZeneca with Torrent, sanofi aventis with Zydus Cadila etc.

5. Global outsourcing in the ‘Contract Research and Manufacturing Services (CRAMs)’’ space

Increasing importance of GSCM:

In today’s evolving scenario, Global Supply Chain Management (GSCM) process has assumed a key importance. The need to reduce costs significantly and minimize the risks associated with the procurement activities of the business, have compelled many innovator companies to extend the activities of their Supply Chain management process to the Global arena, instead of just confining to the local space.

The changing requirements of all hues and types in various areas of the business, like in sales and marketing, manufacturing, research and development etc., have created a challenging, if not a rather volatile operating environment.

Such an evolving scenario will make the GSCM to increasingly play a key role in the overall business process of an organization to ensure that the right products are available at the right place, at the right time, at a right price and following the right processes…Always.

Emerging GSCM hubs:

There is at the same time, a new trend emerging to provide world class outsourcing services, especially from countries like India and China. These initiatives, which in turn will make these two countries the key global outsourcing hubs, are definitely not due to just cost arbitrage. It encompasses increased integrated value proposition for the overseas customers. Cost is just one of the key factors, others being quality, speed and suppliers’ integrity and reliability. Nothing in this value chain is mutually exclusive. GSCM will need to go through a set of complex algorithms to strike a right balance between all these vital parameters.

Importance of GSCM integrity:

In the days to come by, one of the greatest challenges in GSCM will be to improve the supply chain integrity and security. An appropriate definition of integrity for supply chains could be:

“…the requirement that the system performs its intended function in an unimpaired manner, free from deliberate or inadvertent manipulation.”

A safe and secure supply chain is definitely not a new requirement. However, in the list of priority of importance, it has now come up significantly, compared to what it was just a few years back. Though the issue of improving supply chain integrity and security has now assumed global importance, unfortunately, any uniformity in national regulatory requirements for this vital parameter is glaringly missing. Such a lack of regulatory uniformity clearly highlights that the pharmaceutical companies, engaged in manufacturing, are still not aligned with each other on what will be the right way to ensure absolute integrity, safety and security in the supply chain operating process to guarantee patients’ safety.

Globally, many Pharmaceutical Companies are getting engaged in improving supply chain integrity, security and patients’ safety with the introduction RFID. This, as many may know, is an inventory tracking system for improved product traceability, which in turn extends some protection to its customers with genuine products from the genuine pharmaceutical manufacturers. It is worth noting that RFID is just one component of overall patients’ safety initiative.

Along with high tech measures like RFID, to improve supply chain integrity, I reckon, pharmaceutical companies will need to further enhance their respective ‘supplier qualification process’. The process of supplier audits should include all important and critical areas of manufacturing, testing and quality, related to each individual product.

Stringent supplier qualification standard is of prime importance:

Only a stringent supplier qualification process will be able to guarantee integrity, safety and the quality of outsourced products from the suppliers.

An example of a GSCM related tragedy:

Before I conclude, I would like reinforce my recommendation with the example of the ‘Heparin tragedy’ where the supply chain integrity was violated and seriously challenged thereafter.

In the beginning of 2008, there were media reports on serious adverse drug events, some even fatal, with Heparin, a highly-sulfated glycosaminoglycan of Baxter International. Heparin is widely used as an injectable anticoagulant. Baxter voluntarily recalled almost all their Heparin products in the U.S. Around 80 people died from contaminated Heparin products in the U.S. The US FDA reported that such contaminated Heparin was detected from at least 12 other countries.

A joint investigation conducted by Baxter and the US FDA ascertained that the Heparin used in batches associated with the serious adverse drug events was contaminated with over sulfated chondroitin sulfate (OSCS). It was reported that his Heparin was supplied to Baxter by Scientific Protein Laboratories, Changzhou, China.

The cost of OSCS is just a fraction of the ingredient used in Heparin. Being driven by the criminal profiteering motive the manufacturers in Changzhou, China had reportedly used OSCS for highly-sulfated glycosaminoglycan as the former could not be detected by the pharmacopeia test in use, until 2008. This is because OSCS mimics Heparin in the pharmacopeia test. Post this criminal event, at present, all over the world more specific pharmacopeia test methods have been adopted for Heparin.

Conclusion:

Let us all ensure that such a tragedy does not get repeated in future due to a breach in the supply chain integrity, anywhere in the world…for the patients’ sake.

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.

Pfizer and Biocon deal – heralds dawn of a new era for the Biopharmaceuticals Industry of India

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On October 19, 2010, home grown Biotech Company Biocon, based in the IT heartland – Bangalore created a stir in Industry by inking an interesting international corporate business deal with the largest global pharmaceutical company – Pfizer. The deal will bring to Biocon a total sum of US $350 million and enable Pfizer to globally commercialize Biocon’s biosimilar (generic versions of biotechnology medicines) human recombinant insulin and three insulin analogues.

Before this deal, Sanofi-Pasteur, the vaccine business unit of the global major Sanofi-aventis had acquired Shantha Biotech, located at Hyderabad for a sum of Rs 3,750 Crore, in July 2009.

Just a year before the above acquisition in india, on December 11, 2008, Reuters reported, just two days after Merck announced a major push into biosimilar medicines; Eli Lilly signaled similar aspirations. This report, at that time, raised many eyebrows in the global pharmaceutical industry, as it was in the midst of a raging scientific debate on the appropriate regulatory pathways for biosimilar drugs. Be that as it may, many felt that this announcement ushered in the beginning of a new era. An era of intense future competition with biosimilar drugs in the global market, with immense commercial interest. On October 19, 2010 the biosimilar deal between Biocon and Pfizer vindicated this point.

Increasing global interest on biosimilar drugs:

Globally, the scenario for biosimilars started heating up when Merck announced that the company expects to have at least 5 biosimilars in the late stage development by 2012. The announcement of both Merck and Eli Lilly surprised many, as the largest pharmaceutical market of the world – the U.S.A, at that time, was yet to approve the regulatory pathway for biosimilar medicines. However, along with the recent healthcare reform by the Obama administration, the regulatory pathway for biosimilar drugs has now been clearly charted by the US FDA. In the developed world, European Union (EU) had taken a lead towards this direction by putting a robust system in place, way back in 2003.

What then prompts the research based global pharmaceutical companies like Pfizer, Sanofi-aventis, Merck and Eli Lilly to step into the arena of Biosimilar medicines? Is it gradual drying up research pipeline together with skyrocketing cost of global R&D initiatives?

The future global business potential of Biosimilar medicines:

Currently, over 150 different biologic medicines are available in the global pharmaceutical market. However, the low cost biosimilar drugs are available in just around 11 countries of the world, India being one of them. Supporters of biosimilar medicines are indeed swelling as time passes by. At present, the key global players are Sandoz (Novartis), Teva, BioPartners, BioGenerix (Ratiopharm) and Bioceuticals (Stada). With the entry of pharmaceutical majors like, Pfizer, Sanofi-aventis, Merck and Eli Lilly, the global biosimilar market is expected to develop at a much faster pace than ever before. Removal of regulatory hurdles for the marketing approval of such drugs in the US – the largest pharmaceutical market of the world, will be the key growth driver.

Recently, the EU has approved Sandoz’s (Novartis) Filgrastim (Neupogen brand of Amgen), which is prescribed for the treatment of Neutropenia. With Filgrastim, Sandoz will now have 3 Biosimilar products in its portfolio.

Global Market Potential of Biosimilar Drugs:

The biosimilar drug market in the world is estimated to be around U.S. $ 16 billion by 2011. Currently, off-patent biologic blockbusters including Erythropoietin offer an excellent commercial opportunity in this category. By 2013, about 10 branded biologics with a total turnover of around U.S. $ 15 billion will go off-patent, throwing open greater opportunity for the growth of biosimilar drugs internationally.

Biosimilar Drugs in India:

Sales of biosimilar drugs in India are estimated to be around U.S. $ 4 billion by 2011 with scorching pace of growth driven by both local and global demands.

Recombinant vaccines, erythropoietin, recombinant insulin, monoclonal antibody, interferon alpha, granulocyte cell stimulating factor like products are now manufactured by a number of domestic biotech companies like Biocon, Panacea Biotech, Wockhardt, Emcure, Shantha Biotech, Bharat Biotech, Serum Institute of India, Dr. Reddy’s, Ranbaxy, etc. The ultimate objective of all these Indian companies will be to get regulatory approval of these products in the US and the EU either on their own or through collaborative initiatives.

It is worth mentioning here that to give a fillip to the Biotech Industry in India; the National Biotechnology Board was set up by the Government of India under the Ministry of Science and Technology way back in 1982. The Department of Biotechnology (DBT) came into existence in 1986. The DBT now spends around US$ 200 million annually to develop biotech resources in the country and have been making reasonably good progress. The DBT is reported to have undertaken an initiative for quite some time to prepare regulatory guidelines for Biosimilar Drugs, which is expected to conform to international quality and patients’ safety standards.

Steps taken by the Indian pharmaceutical companies:

Biosimilar version of Rituxan (Rituximab) of Roche used in the treatment of Non-Hodgkin’s lymphoma has already been developed by DRL in India. Last year Rituxan clocked a turnover of over US$ 2 billion. DRL also has developed filgastrim of Amgen, which enhances production of white blood-cell by the body, and markets the product as Grafeel in India. Similarly Ranbaxy has collaborated with Zenotech Laboratories to manufacture G-CSF.

On the other hand Glenmark is planning to come out with its first biotech product by 2011 from its biological research establishment located in Switzerland.

The focus is on Oncology:

Many domestic Indian pharmaceutical companies are targeting Oncology disease area for developing biosimilar drugs, which is estimated to be the largest segment with a value turnover of over US$ 55 billion by the end of 2010 growing over 17%. As per recent reports about 8 million deaths take place all over the world per year due to cancer. May be for this reason the research pipeline of NMEs is dominated by oncology with global pharmaceutical majors’ sharp R&D focus and research spend on this particular therapy area. About 50 NMEs for the treatment of cancer are expected to be launched globally by 2015.

Current size of the Indian oncology market is around US$ 18.6 million, which is expected to be over US$ 50 million by the end of 2010; the main reason being all these are and will be quite expensive products.

A trigger point for more collaborative initiatives:

It is expected that the recent Pfizer – Biocon deal will trigger many other collaborative initiatives between the global and the local pharmaceutical companies.

Among India biotech companies, Reliance Life Sciences has already marketed Recombinant Erythropoietin, Recombinant Granulocyte Colony Stimulating Factor, Recombinant Interferon Alpha and Recombinant tissue plasminogen activator. This company has been reported to have the richest pipeline of biosimilar drugs in India. Companies like Wockhardt, Lupin, DRL and Intas Biopharmaceuticals are also in the process of developing an interesting portfolio of biosimilar drugs in India to fully encash the fast growing global opportunities.

Biosimilar global business model will fast gain ground:

Many large research-based global pharmaceutical companies, after having encountered the ‘patent cliff’, are now looking at the generic and biosimilar businesses, in a mega scale, in the emerging markets of the world, like India. Our country has witnessed major acquisitions like, Ranabaxy, Shantha Biotech and Piramal Healthcare by Daiichi Sankyo of Japan, Sanofi-aventis of France and Abbott of USA, respectively. We have also seen collaborative initiatives of large global companies like, GSK, AstraZeneca, and Pfizer with Indian companies like DRL, Aurobindo, Claris, Torrent, Zydus Cadilla, Strides Arcolab and now Biocon to reach out to the fast growing global generic and biosimilar drugs markets.

This trend further gained momentum when immediately after Biocon deal early this week, on October 21, 2010, Pfizer strengthened its footprints in the global generics market with yet another acquisition of 40% stake in Laboratorio Teuto Brasilieiro of Brazil with US $240 million to develop and globally commercialize their generic portfolio.

Conclusion:

All said and done, the recent international deal of Pfizer and Biocon to globally commercialize four biosimilar insulin and analogues, developed by the later in India, does signal a new global status for the Indian biosimilar drugs to the pharma MNCs, who were vocal critics of such drugs developed in India, until recently.

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.

Indian Pharmaceutical Industry could well be a contender for global supremacy by the next decade, competing effectively with China

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By the next decade of this millennium both India and China are expected to be the top two emerging markets of the world in the pharmaceutical sector, registering a scorching pace of growth all around. The quality of consistency and sustainability of growth, will determine who will be the main contender of supremacy and the ultimate winner in this game of wealth creation for the respective countries and be the ‘Eldorado’ of the global pharmaceutical companies.

The financial reform measures in the run up to the process of globalization started earlier in China, in 1980 as against 1990 in India. In that sense China took a plunge to be an active member of the ‘global village of commerce’ at least a decade earlier than India.

Reform process started earlier in China:

The Product Patent regime in India was reintroduced in January 1, 2005. Well before that China started creating and encouraging a large number of independently funded pharmaceutical R&D institutions to create an environment of innovation within the country. Many of these institutions are now viable profit centres, creating wealth for the country.

At the same time, focusing on global ‘economies of scale’, Chinese pharmaceutical players have now become globally competitive, may be a shade better than India. Clear dominance of China in the business of ‘Active Pharmaceutical Ingredient (API)’ among many other, will vindicate this point. On the other hand in the formulations business, India is miles ahead of China, catering to over 20% of the global requirements for the generic pharmaceuticals. Moreover, in ANDA and DMF filings, as well, India is currently much ahead of China.

FDI in India and China:

The Pharmaceutical Industry in India has now started attracting increasing Foreign Direct Investments (FDI). As per the reply to question No. 615 tabled in the Parliament of India (Rajya Sabha) on November 25, 2009 by Mr. Jyotiraditya Scindia, Minister of State, Ministry of Commerce and Industry, from the year 2006-07 up to September 2009, India attracted FDI of US $ 817.30 million for Drugs and Pharmaceuticals with a compounded growth rate of around 60%. USA, Canada, Singapore, UAE and Mauritius contributed 82% to this FDI, which in turn helped significantly to fuel further development and growth of the Industry.

According to ‘The Survey of Foreign Investments in China’s Medicine Industry’ of the Government of China, the FDI in the pharmaceutical industry of the country for the three year period commencing from 2006 to 2008 was around US $ 1772 million, over one third of which coming from Hong Kong and around 11% from the USA.

It is worth noting that the financial and policy reform measures were initiated in China much earlier, as compared to India, which in turn have enabled China to attract more FDIs in the pharmaceutical sector, thus far. In the new paradigm of the post product patent regime both the countries are expected to grow at a scorching pace attracting more and more FDIs for their respective countries.

In this article, I would like to focus on some of these comparisons to assess the progress made so far by both the countries, in a comparative yardstick and the key factors, which will decide the pace-setter.

Country ranking both in value and growth terms:

In global ranking, China is currently the seventh (India: 14) largest pharmaceutical market and is expected to be the fifth (India: 10) largest market by 2015 and the third largest by 2020. Chinese pharmaceutical market is expected to grow by over 15% per annum in the next five years, which is higher than India.

Healthcare coverage of population:

China is racing ahead and gradually but surely distancing itself from India, widening the performance gap with rapid increase of domestic consumption of modern medicines. It is worth mentioning that as per WHO, the access to modern medicines in China is around 85% as against just 35% in India. Of a population of 1.3 billion, 250 million of Chinese are covered by health insurance, another 250 million partially covered by insurance and balance 800 million are not covered by any insurance. In India total number of people who are having some sort of healthcare financing coverage will be around 200 million and penetration of health insurance will be just around 3.5% of the population.

Currently India is losing grounds to China mainly in healthcare infrastructure development, with inadequate healthcare delivery systems and delay in rolling out a long overdue comprehensive healthcare reform process in the country.

Strong commitment of the Chinese Government to the globalization process:

Strong commitment of the Chinese Government to make China a regional hub of R&D and contract research and manufacturing (CRAM) activities within next seven to ten years is paying rich dividends.
Department of Pharmaceuticals recently expressed its intention to make India a R&D hub in not too distant future. This cannot be achieved just through investments of couple of million US $ through Public Private Partnership (PPP). A strong commitment of the Government to hasten regulatory reform processes will be the key factor. The new product patent regime for the pharmaceutical industry has ushered in a new paradigm, with the Government planning to strike a right balance between TRIPs compliant IPR regime and the ‘Public Interest’ and NOT one at the cost of the other.

India and China competing well in Pharma outsourcing business:

Since last 5 years both India and China have made rapid strides in the space of pharma outsourcing. Today the evolving business model of ‘Contract Research and Manufacturing Services (CRAMS)’, is shaping up quite well. To make India a global hub for Pharmaceutical outsourcing of all types, the pharmaceutical industry of the country has all the ingredients. India has the potential to emerge as a serious contender for global supremacy, in this fast growing sector, especially in ‘contract manufacturing’ area, having largest number of US-FDA approved manufacturing plants, outside the USA.

According to ‘Global Services”, in 2009 Pharmaceutical outsourcing market in China and India was of US $ 1.77 billion and US $ 1.42 billion, respectively with China growing at a faster pace. The future growth potential for both the countries is huge, as each enjoyed just 2% share of this outsourcing market in 2009.

It has been forecasted that China will have more environmental growth accelerators than India due to greater continuing fiscal stimulus and policy support by their Government, which could catapult the country ahead of India, just beyond 2010.

‘Country Attractiveness Index’ for clinical trials:

‘A.T. Kearney’ developed a ‘Country Attractiveness Index (CAI)’ for clinical trials, for the use of, especially, the pharmaceutical industry executives to make more informed decision on offshore clinical trials. As per this study, the CAI of China is 6.10 against 5.58 of India.

Pharmaceutical patent filing:

In patent filing too China seem to be ahead of India. Based on WIPO PCT applications, it has been reported that 5.5% of all global pharmaceutical patent applications named one inventor or more located in India as against 8.4% located in China. This will give an Indication how China is making rapid strides in R&D areas, as well.

Where India is regarded clearly as a preferred destination:

However, India is globally considered as a more mature arena for chemistry and drug-discovery activities than China. Most probably because of this reason, companies like, DRL, Aurigene, Advinus, Glenmark, Nicholas Piramal and Jubilant Organosys could enter into long-term deals with Multinational Companies (MNCs) to discover and develop New Chemical Entities (NCEs).

Pharmaceutical exports, by end 2010:

India is currently an attractive pharmaceutical outsourcing destination across the globe. Pharmaceutical exports of India is currently far ahead of China. However, PriceWaterhouseCoopers (PWC) reports that China may reverse this trend by the end of 2010, establishing itself as the largest country for Pharmaceutical exports. In API exports China has already overtaken India, way back in 2007. The report titled, “The Changing dynamics of pharmaceutical outsourcing in Asia” indicates that in 2007 against API exports of U.S$ 1.7 billion of India, China clocked a figure of US$ 5.6 billion. By the end of 2010, China is expected to widen the gap further with API export of U.S$ 9.9 billion against India’s U.S$ 2.8 billion.

Korn/Ferry International reports that more and more Indian talent is being pulled to China to fill key roles, especially in the API sector, signaling ‘brain drain’ from India to China.

Conclusion:

As I said earlier and as has been reported by Korn/Ferry, China’s current overall infrastructure in the pharmaceutical space is better than India primarily due to firm commitment of the Chinese government to initiate reform measures to fetch maximum benefits of globalization process in the country. Government of India seems to be lacking in its commitment to play its role both as a provider and also as an effective enabler in this important space of ‘knowledge economy’ of the world.

India has all the potential to surge ahead with more rapid strides in this ball game. To achieve this cherished goal, the government, other stakeholders and the domestic pharmaceutical Industry should play the ball well, effectively, and in tandem.

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.

Prescribing 10 steps for comprehensive Healthcare Reforms in India

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Recently President Barack Obama, by enacting historic healthcare reform legislation, fulfilled his election campaign pledge to provide healthcare to all in the United States of America. This piece of legislation will provide health insurance benefits to another around 34 million poor and uninsured Americans. The key highlight of this health insurance scheme is that it will compel the insurers to extend insurance to even those with any pre-existing illness and impose stringent criteria on expenditure towards medical treatment to cut healthcare costs. The new healthcare reform will cost around US $940 billion over 10 years to the US Government. To partly recover this cost, President Obama administration will levy new fees to the healthcare and pharmaceutical companies along with a new tax for the high income groups.

So far as healthcare reform in the US is concerned, President Obama, has therefore, ‘walked the talk’.

Closer home, just prior to the US healthcare reform, our Prime Minister Dr. Manmohan Singh reiterated in his speech delivered at the 30th Convocation of PGIMER, Chandigarh on November 3, 2009, the dire need of the country to strike a right balance between preventive and curative healthcare for the common man. The Prime Minister articulated his thoughts as follows:

” We must also recognize that a hospital centered curative approach to health care has proved to be excessively costly even in the advanced rich developed countries. The debate on health sector reforms is going on in US is indicative of what I have mentioned just now. A more balanced approach would be to lay due emphasis on preventive health care”.

However, the Prime Minister has not walked the talk, not just yet.

The key issues of Indian healthcare system:

Access: mostly due to inadequate healthcare infrastructure and affordability issues
Affordability: Socio-economic complexities and lack of adequate healthcare financing model in the country

Some key research findings on ‘Public Health’:

Interesting research studies on public health highlight two very interesting points:

- Health of an individual is as much an integral function of the related socio-economic factors as it is
influenced by the person’s life style and genomic configurations

- Socio-economic disparities including the educational status lead to huge disparity in the space of
healthcare.

Tweaking of the existing system is not enough:

An increase in allocation of Rs. 27,000 for healthcare, over the previous year, in the Union Budget 2010-11 covering as large as 1.13 billion population, is just not enough. The public expenditure towards healthcare, as indicated by Dr. Manmohan Singh should be around 2.5% – 3% of the GDP, against the current expenditure on the same of just 1%. To effectively address the key issues of affordability and access to healthcare the country will need a radical reform in its healthcare space with a sharp focus on preventive healthcare of the population of the country, education and related critical socio-economic issues, as has already been enunciated by the Prime Minister of our country.

Where does India stand in the ‘World’s Health Systems’:

The WHO ranking of the ‘World’s Health Systems’ was last produced in 2000. This report is no longer produced by the WHO due to huge complexity of the task.

In this interesting report, the number one pharmaceutical market of the world and the global pioneer in pharmaceutical R&D, the USA features in no. 37, Japan in no. 10, UK in no.18 and France tops the list with no.1 ranking. Among emerging BRIC countries, India stands at no. 112, Russia in no.130 and China in no. 144.

In a relative yardstick, although India scored over the remaining BRIC countries in year 2000, one should keep in mind that China has already undertaken a major healthcare reform in the last year. As stated before, earlier this year, we all have seen how President Obama introduced a new healthcare reform for the USA, despite all odds. India’s major reform in its healthcare space is, therefore, long overdue, which will require similar leadership passion to make it happen.

No need to reinvent the wheel:

When we look at the history of development of the developed countries of the world, we observe that all of them had invested and are continuously 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 always proved to be the most effective drivers of economic growth. This is a work in continuous progress. Recent healthcare reforms both in China and the USA will vindicate this argument. In India we, therefore, do not require to reinvent the wheel, any more.

It has been observed that reduction of social inequalities ultimately helps to effectively resolve many important healthcare issues. Otherwise, the minority population with adequate access to knowledge, social and monetary power will always have necessary resources available to address their concern towards healthcare, appropriately.

A recent report from KPMG also reiterates “One of the major challenges remains the need to develop scalable and sustainable healthcare delivery models to deal with India’s diversity and changing socio-economic population profiles”.

Path breaking medicines are desirable, but just not enough:

Regular flow of newer and path breaking medicines in India to cure and effectively treat many diseases, have not been able to eliminate either trivial or dreaded diseases, alike. Otherwise, despite having effective curative therapy for malaria, typhoid, cholera, diarrhea/dysentery and venereal diseases, why will people still suffer from such illnesses? Similarly, despite having adequate preventive therapy, like vaccines for diphtheria, tuberculosis, polio, hepatitis and measles, our children still suffer from such diseases.

Reducing socio-economic inequalities is equally important:

All these continue to happen in India, over so many decades, because of socio-economic considerations, as well. Thus, together with comprehensive healthcare reform measures, time bound simultaneous efforts to reduce the socio-economic inequalities will be essential to achieve desirable outcome for the progress of the nation.

Proper focus on education is critical for a desirable health outcome:

Education is of key importance to make any healthcare reform measure to work effectively. 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 process.

Sharp focus on both education and healthcare is very important to realize the economic potential of any nation. India will not be able to realize its dream to be one of the economic superpowers of the world without this focus and significant resource allocation in these two critical areas – Health and Education, simultaneously.

Progress in the healthcare space of India:

It sounds quite unfair, when one comments that nothing has been achieved in the area of healthcare in India, as is usually done by vested interests with a condescending attitude in various guises. Since independence, India has made progress, may not be highly significant though, with various government sponsored and private healthcare related initiatives, as follows:

- Various key disease awareness/prevention programs across the country, for both communicable and
non-communicable diseases.
- Eradication of smallpox
- Excellent progress in polio eradication program
- Country wide primary vaccination program
- Sharp decline in the incidence of tuberculosis
- Significant decrease in mortality rates, due to water-borne diseases.
- Good success to bring malaria under control.
- The mortality rate per thousand of population has come down from 27.4 to 14.8 percent.
- Life expectancy at birth has gone up to 63 years of age.
- Containment of HIV-AIDS
- India has been recognized as the largest producers and global suppliers of generic drugs of all
categories and types.
- India has established itself as a global outsourcing hub for Contract Research and Contract
Manufacturing Services (CRAMS).
- The country has now been globally recognized as one of the fastest growing emerging markets for
the pharmaceuticals

Recent healthcare initiatives in India:

There are various hurdles though, to address the healthcare issues of the country effectively. However, these are not definitely insurmountable. ‘National Rural health Mission (NRHM)’ is indeed an admirable scheme announced by the Government. Similar initiative, like, ‘Rashtriya Bima Yojana (RBY)’ to provide health insurance program for below the poverty line (BPL) population of the country, is also equally commendable. However, effectiveness of all such schemes will warrant effective leadership at all levels of their implementation.
Per capita public expenditure towards healthcare is inadequate:

Per capita public expenditure towards healthcare in India is (please see below) much lower than China and well below other emerging countries like, Brazil, Russia, China, Korea, Turkey and Mexico.

Although spending on healthcare by the government gradually increased in the 80’s, overall public spending as a percentage of GDP has remained quite the same or marginally decreased over last several years. However, during this period private sector healthcare spend has increased to around 4.5 per cent of the GDP.

It appears, the government of India is gradually changing its role from the ‘healthcare provider’ to the ‘healthcare enabler’.

High ‘out of pocket’ expenditure towards healthcare in India:

According to a study conducted by the World Bank, per capita healthcare spending in India is around Rs. 32,000 per year and as follows:

- 75 per cent by private household (out of pocket) expenditure
- 15.2 per cent by the state governments
- 5.2 per cent by the central government
- 3.3 percent medical insurance
- 1.3 percent local government and foreign donation

Out of this expenditure, besides small proportion of non-service costs, 58.7 percent is spent towards primary healthcare and 38.8 percent on secondary and tertiary inpatient care.

Role of the government:

In India the national health policy falls short of specific and well defined measures.

Health being a state subject in India, poor coordination between the center and the state governments and failure to align healthcare services with broader socio-economic developmental measures, throw a great challenge in bringing adequate reform measures in this critical area of the country.

Healthcare reform measures in India are governed by the five-year plans of the country. Although the National Health Policy, 1983 promised healthcare services to all by the year 2000, it fell far short of its promise.

Underutilization of funds:

It is indeed unfortunate that at the end of most of the financial years, almost as a routine, the government authorities surrender their unutilized or underutilized budgetary allocation towards healthcare. This stems mainly from inequitable budgetary allocation to the states and lack of good governance at the public sector healthcare delivery systems.

Encourage deep penetration of ‘Health Insurance’ in India:

As I indicated above, due to unusually high (75 per cent) ‘out of pocket expenses’ towards healthcare services in India, a large majority of its population do not have access to such quality, high cost private healthcare services, when public healthcare machineries fail to deliver.

In this situation an appropriate healthcare financing model, if carefully worked out under ‘public – private partnership initiatives’, is expected to address these pressing healthcare access and affordability issues effectively, especially when it comes to the private high cost and high quality healthcare providers.

Although the opportunity is very significant, due to absence of any robust model of health insurance, just around 3 percent of the Indian population is covered by the organized health insurance in India. Effective penetration of innovative health insurance scheme, looking at the needs of all strata of Indian society will be able to address the critical healthcare financing issue of the country. However, such schemes should be able to address domestic and hospitalization costs of ailments, broadly in line with the health insurance model working in the USA.

The Government of India at the same time will require bringing in some financial reform measures for the health insurance sector to enable the health insurance companies to increase penetration of affordable health insurance schemes across the length and the breadth of the country. It is encouraging that the Deputy Chairman of the Planning Commission of India, Mr. Montek Singh Ahluwalia has recently commented to the media that the commission is working on it.

A 10 pronged strategy prescribed:

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

1. Government should assume the role of provider of preventive and basic primary healthcare across the
nation to ensure adequate access to healthcare for the entire population of 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. The issue of affordability of medicine can best be addressed by putting in place a robust model of
healthcare financing for all sections of the population of the country. Through PPP a strong and
highly competitive health insurance infrastructure needs to be created through innovative fiscal
incentives.

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

9. Make operations of 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. The US
model of Medicare and Medicaid could be examined in this regard..

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

Conclusion:

A comprehensive healthcare reform in India is long overdue. The magnitude of the task is equally daunting. The pace of change in the healthcare space of the country has been very slow over the last six decades, despite sharp ascending GDP growth trend of the nation. Private sector can play the role of the game changer, provided government plays the role of an effective enabler through various policy measures, fiscal/ other incentives and by creating enough competition within the healthcare providers. Such healthy competition will trigger introduction of innovative healthcare solution models, the ultimate beneficiary of which will be none other than the patients. Health being a state subject in India and as the respective state governments control healthcare spending, quality of involvement of all the states in this reform process will determine its success or failure.

Right to education has now become a fundamental right of the citizens of the country. Will right to health continue to remain far behind?

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 China provide a more robust IPR environment than India?

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Soon after the Product Patent Act was reintroduced in India effective January 1, 2005, a raging global debate commenced focusing on the robustness of the Indian Patent system. Quite often, many participants in the debate continue to compare the adequacies of the Chinese patent system with the inadequacies of the same in India.

‘The Pharma Letter’ dated October 26, 2010 published an Article captioned, “Intellectual property concerns and domestic bias hold back R&D in Asia-Pacific.”

Asia-Pacific still lags behind in terms of global R&D investments:

Unlike the common perception in India that China is attracting a significant part of the global investments towards R&D, latest data of MedTRACK revealed that only 15% of all drugs development are taking place in Asia-Pacific despite the largest growth potential of the region in the world. The Pharma Letter also reported, “In December 2009, China unveiled that it would give domestic companies making innovative products an advantage in qualifying for government purchases. This measure is likely to further limit foreign investment in product development in China, and negatively affect growth of foreign brands.”

Such type of domestic bias and protectionist’s measures are yet to be witnessed in India.

Since US is a pioneering country in the field of global R&D and its commercial interest related to such initiatives spans across the globe, let me try to analyze this subject, in this article, quoting only from official US publications.

IPR environment in China – the US perspective:

So far as the current IPR environment in China is concerned, US Embassy based in that country has commented as follows:

“Despite stronger statutory protection, China continues to be a haven for counterfeiters and pirates. According to one copyright industry association, the piracy rate remains one of the highest in the world (over 90 percent) and U.S. companies lose over one billion dollars in legitimate business each year to piracy. On average, 20 percent of all consumer products in the Chinese market are counterfeit. If a product sells, it is likely to be illegally duplicated. U.S. companies are not alone, as pirates and counterfeiters target both foreign and domestic companies”.

In the same context the following remarks of Mr. Shaun Donnelly, Senior Director, International Business policy, National Association of Manufacturers (NAM) , USA, made at the Intenational Trade Commission on June 15, 2010 on IPR environment in China, is also quite interesting:

“Unfortunately China remains Ground Zero for international product counterfeiting and Piracy. Despite considerable efforts over many years by US Government agencies and other international partners as well as Chinese Government the Progress has been minimal…. China continued to be the number one source country for pirated goods seized in the US borders accounting for 79% of the total seizures…The top sectors of IPR infringing products seized included footwear, consumer electronics, apparel, computer hardware, pharmaceuticals…”

Patent enforcement in China – the US perspective:

Regarding product patent enforcement is concerned the US Embassy in China comments:

“Though we have observed commitment on the part of many central government officials to tackle the problem, enforcement measures taken to date have not been sufficient to deter massive IPR infringements effectively. There are several factors that undermine enforcement measures, including China’s reliance on administrative instead of criminal measures to combat IPR infringements, corruption and local protectionism, limited resources and training available to enforcement officials, and lack of public education regarding the economic and social impact of counterfeiting and piracy”.

“Notwithstanding the increased number of applications, many patent owners (both foreign and domestic) continue to experience problems with infringement in China. Counterfeiting and other infringing activities are rampant, and critics frequently complain of lax enforcement of intellectual property laws. As a result, any party considering introducing a patented (or patentable) technology into China – especially one that could be easily reverse engineered or duplicated – would be well advised to proceed with extreme caution, seek legal advice from the outset, and plan fastidiously”.

Regulatory Data Protection (RDP) in India:

Regulatory Data Protection (RDP) for Pharmaceutical Products is still not in place in India, as the Government of India has already articulated that RDP is a ‘TRIPS Plus’ requirement and is non-binding to the country. The Government further reiterated that if any or more interested parties will feel that it is not so, they can certainly go to the WTO forum for the redressal of their grievances in this matter.

RDP in China – the US perspective:

However, on this subject the US feels that though RDP for a 5 year period is now in place in China, ‘inadequacies in their current regulatory environment allow for unfair commercial use of safety and efficacy data generated by the global innovator companies.”

In such a scenario the sanctity of RDP gets significantly diluted and may prove to be a virtually meaningless exercise.

Conclusion:

R. Fernando and D. Purkayastha of ICMR Center for Management Research in their article titled, “Pfizer’s Intellectual Property Rights Battles in China for Viagra” had commented as follows:

“Though the foreign research-based pharmaceutical companies were not happy with the lax IPR regime, the booming Chinese pharmaceutical market provided enough incentive for these companies to stay put and fight it out with the local firms for a share in this emerging market”.

Under these circumstances, while recommending for a world class robust patent regime in India to foster innovation in the country, if anybody wants to draw examples from China on the subject, it would indeed be foolhardy.

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.

India needs ‘Orphan Drugs Act (ODA)’ to counter growing threat of dreaded rare diseases and simultaneously boost global growth potential of the Indian Pharmaceutical Industry

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An orphan disease is a rare and uncommon disease and an ‘Orphan Drug’ is a pharmaceutical substance that has been developed to treat an orphan disease. The US FDA defines a rare disease, with a prevalence of 1 in 5,000 of the general population, whereas in the European Union (EU) defines it as a disease with a prevalence of 5 in 10,000 of the population.

Around 6-8% of the world population is manifested by such rare diseases. There are around 5000 of reported rare diseases with an ascending growth trend.

Despite such trend, high drug development cost coupled with low return on investment, do not encourage many innovator pharmaceutical companies to get engaged in R&D initiatives for such drugs. However, this perception is fast changing, as we shall see below.

US took the first step to encourage commercialization of ‘Orphan Drugs’:

Public awareness drives for ‘Orphan Diseases’ first originated in the USA with the formation of a rare disease support group representing around 200,000 patients suffering from such diseases. This awareness campaign ultimately culminated into a path breaking legislation in the US named, ‘Orphan Drugs Act’ (ODA), in 1983. The key purpose of ODA was to incentivize initiatives towards development of such drugs to treat around 25 million Americans suffering from ‘Orphan diseases’. The incentives included:

- Funding towards investigation for “Orphan Disease’ treatment
- Tax credit for Clinical Research
- Waiver of fees for New Drug Application (NDA)
- Offering more lucrative incentive than product patent (product patent requires the drug to be novel), as the orphan designation of the product by the US FDA and product approval by them are the only requirements for 7 year market exclusivity of an ‘Orphan Drug’ for the same indication.
- Market exclusivity of ‘Orphan Drugs’ become effective from the date of regulatory approval, unlike product patent, product development time remains outside this period.
- The drugs, which are not eligible for product patent, may be eligible for market exclusivity as an ‘Orphan Drug’ by the US-FDA

Thanks to this Act, currently around 230 ‘Orphan Drugs’ are available in the US for the treatment of around 11 million patients suffering from rare diseases. With the help of ‘Human Genome Project’ more orphan diseases are expected to be identified and newer drugs will be required to treat these rare ailments of human population.

1983 signaled the importance of ‘Orphan Drugs’ with the ODA in the US. A decade after in 1993, Japan took similar initiative followed by Australia in 1999. Currently, Singapore, South Korea, Canada and New Zealand are also having their country specific ODAs.

India needs ODA:

Unfortunately in India, we do not have any ODA, as of now. Such legislation could give a new fillip to the Indian Pharmaceutical and Bio-Pharmaceutical industry and at the same time usher in a new hope to thousands of patients suffering from rare diseases in India, with the availability of relatively lower cost medications to them.

The global market:

The global market of ‘Orphan Drugs’ is expected to grow to US $ 112 billion in 2014 from US $85 billion in 2009. Biotech products contribute around 70% of this turnover with relatively higher CAGR growth rate of around 7%. However, reluctance of the insurance companies to cover ‘Orphan Drugs’ due to higher price still remains a global issue.

Orphan drugs to create a paradigm shift in the Pharmaceutical Industry: says Frost & Sullivan:

“While the pharmaceutical industries have been focusing on ‘blockbuster’ small molecules (chemical drugs) for high revenue generation in the past, it is expected that in 5 years, around $90.0 billion worth of branded drugs will lose their exclusivity. The current economic situation plus the huge generic competition shifted the focus of pharmaceutical companies and they are moving to a new business model – ‘Niche busters’, also called Orphan drugs.”

It is believed that Orphan drugs will now offer an attractive opportunity to the pharmaceutical companies than ever before to significantly absorb the impact of the ‘Patent Cliff’. Various financial incentives provided by the governments of various countries under the ODA coupled with many smaller collaborative projects towards this direction will further encourage the global pharmaceutical players to develop ‘Orphan Drugs.

Currently, EU has granted over 700 ‘Orphan Designations’ and over 60 new drugs have received favorable response for Market Authorization.

Sales potential for ‘Orphan Drugs’:

Generally ‘Orphan Drugs’ were not expected to be very high revenue earners. However, about 4 year ago in the year 2006, about 50 ‘Orphan Drugs’ were reported to had crossed a sales turnover of US $200 million. In 2006 the following ‘Orphan Drugs’ with expired market Exclusivity in the US, had assumed blockbuster status:

- Enbrel (Immunex): US $ 4.38 billion
- Rituxan (Genentech): US$ 3.97 billion
- Nupogen/Neulasta (Amgen): US $ 3.92 billion
- Epogen (Amgen): US $ 2.50 billion
- Avonex (Biogen): US $ 1.70 billion
- Betaseron (Novartis & Bayer): US $ 1.33 billion
- Intron A/ PEG-Intron (Schering): US $ 1.07 billion
- Kogenate (Bayer): US $ 1.07 billion
- Ceredase/Cerezyme (Genzyme): US $ 1.00 billion

Key growth drivers for ‘Orphan Drugs’:

In my view the following key factors will play critical role in driving the growth for ‘Orphan Drugs’:

- Market exclusivity options for a number of FDA recognized ‘Orphan Indications’ for the same drug
- Market exclusivity for seven years in the U.S. and ten years in the EU for each of the ‘Orphan Indications’
- Oncology could be a good segment to get such multiple ‘Orphan Indications’ for the same molecule

Glivec of Novartis obtained approval for around five new ‘Orphan Indications’, the key indications being Chronic Myelogenous Leukemia (CML) and Gastrointestinal Stomal Tumors. The product has already assumed a global blockbuster status with an estimated sales turnover of over US $4 billion by 2011.

Biotech companies are champions for the development of ‘Orphan Drugs’, globally:

Since long, the Biotech companies are taking initiatives for the development of ‘Orphan Drugs’. The path breaker in this respect was Genentech of the US, which developed two growth hormone molecules with names Protophin and Nutrophin, way back in 1985. Now, having realized the hidden potential of this segment more number of pharmaceutical players are entering into this arena. Thus, it is no wonder that 13 out of 19 blockbuster ‘Orphan Drugs’ were biologics in the year 2006.

Conclusion:

It is interesting to note that some of the ‘orphan diseases’ are now being diagnosed in India, as well. As India takes rapid strides in the medical science, more of such ‘Orphan Diseases’ are likely to be known in our country. Thus the moot question is how does India address this issue with pro-active measures?
Currently, India is curving out a strong niche for itself in the space of biogenerics. Pfizer-Biocon deal will vindicate this point.

Moreover, with Pharmacogenomics keep gaining ground at a faster pace, as I mentioned earlier, there will be a shift towards personalized medicines, in not too distant future, in which case the blockbuster drugs as defined today, will be effective only for a smaller number of patients. If the Government of India visualizes this scenario sooner, and comes out with appropriate ODA for the country, domestic pharmaceutical industry of India, in general and biopharmaceuticals industry of the country, in particular, will be able emerge as a force to reckon with, in this important global space, much faster than what one would currently anticipate.

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.

Pragmatic intervention of all the states for Preventive Healthcare could significantly reduce the burden of disease of ‘We, the People of India’.

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Overall disease pattern in India is showing a perceptible shift from the age old ‘Infectious Diseases’ to ‘Non-infectious Chronic Illnesses’. As reported by IMS, incidence of chronic ailments in India has increased from 23% in 2005 to 26% in 2009.

It is estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade in the country, significantly increasing the burden of disease across the socio-economic strata of the nation. It goes without saying that poor people will be hit harder, if corrective actions are not undertaken right now.

As a consequence of such changing disease pattern, healthcare needs and related systems of the country should undergo a paradigm shift together with the emergence of a carefully planned concept of ‘Preventive Healthcare’ for the entire population of the nation.

It is a myth that non-infectious illnesses are more prevalent in higher socio-economic strata:

There is a common perception that Non-Communicable Diseases (NCDs) are more prevalent within higher socio-economic strata of the society. However, a national survey done in India shows that diseases related to misuse of alcohol and tobacco are higher in the poorest 20 percent quintile of our society.

However, a research recently study done in 1600 villages, spanning across 18 states of India and published on the September 27, 2010 edition of the British Medical Journal (BMJ), reported that the risk-factors of non-communicable diseases are high in rural India, which is the home of over 70% of the population of India. (Non-communicable Disease Risk Factors High in Rural India.

As this population has limited access and affordability to healthcare in general, the situation demands greater importance and focus.

Risk-factors of NCDs in rural India:

The above BMJ study highlighted prevalence of the following key risk-factors for the vulnerable population:

• Tobacco use (40% men, 4% women)
• Low fruit and vegetable intake (69% men, 75% women)
• Obesity (19% men, 28% women)
• High cholesterol (33% men, 35% women)
• Hypertension (20% men, 22% women)
• Diabetes (6% men, 5% women)
• Underweight (21% men, 18% women)

Current healthcare system in India:

Currently with appropriate disease treatment measures, alleviation of acute symptoms of the disease that a particular patient is suffering from, is the key concern of all concerned, starting from the doctors to the patients including their families. The process of the medical intervention revolves round treatment protocols and procedures based on the diagnosis of the current ailments and not so much on preventive measures for other underlying diseases, except with the use of vaccines for some specific diseases.

Developing a protocol for ‘Preventive Healthcare’ for non-communicable diseases is very important:

In the above process, while addressing the acute problems of the patients’ current ailments is very important, proper risk assessment of other underlying diseases, if any, which the patient could suffer from in future, for various reasons, do not attract any organized attention. As a result the important advice on preventive healthcare from the doctors, properly highlighting its importance, is not available to most of the patients to enable them to significantly reduce, if not eliminate, their future burden of disease.

Keeping such common practices in view and noting that ‘Preventive Healthcare’ is significantly different from ‘Curative Healthcare’, developing an appropriate protocol for ‘Preventive Healthcare’ has become a crying need of the hour.

‘Preventive Healthcare’ in India should attract high priority of the healthcare policy makers with a careful vigil on its effective implementation at the ground level:

All said and done, the ‘Preventive Healthcare’ system in India is in its very nascent stage. If appropriate measures are taken in this area, like learning to reduce the impact of mental and physical stress, avoiding sedentary life style, taking healthy diet, avoidance of tobacco and alcohol consumption, leading healthy sex life etc., it can in turn immensely help the population to remain disease free and healthy, thereby contributing to improvement of their respective work productivity in a very substantial way.

Recently re-structured Medical Council of India should also step in:

Thus the role of medical professionals in the disease prevention process is also very important. The interaction of the patients with the doctors when they meet to address any ailment provides huge opportunity to the doctors to advise those patients about various measures of underlying disease prevention, for which different patients have different types of exposures.

Keeping all these points in view, through regulatory initiatives, the newly restructured Medical Council of India (MCI) should consider making ‘Preventive Healthcare’ an integral part of each interaction of a patient with a doctor.

Include the civil society in the preventive healthcare initiatives:

The risk factors of many of the diseases like, cancer, chronic respiratory disorders, cardiovascular, diabetes, and hypertension can be identified well in advance and appropriately assessed. Therefore, such diseases can be prevented effectively, to a great extent, provided the healthcare policy of the country supports the ‘Disease Prevention’ process, program and initiatives through adequate resource allocation, improving awareness of the civil society and above all including them in this healthcare improvement process of the nation.

Need to raise general awareness towards ‘Preventive Healthcare’:

Raising the level of awareness of ‘Preventive Healthcare’ is indeed very important. It requires a change in the mindset of the community in general, together with the healthcare policy makers, medical profession, employers, patients and their families.

National Non-Communicable Disease (NCD) prevention program of the government:

As per the planning commission, the government of India has initiated the following structured measures for the prevention of NCD:

• “Health education for primary and secondary prevention of NCDs through mobilizing community action;
• Development of treatment protocols for education and training of physicians in the prevention and management of NCDs:
• Strengthening/creation of facilities for the diagnosis and treatment of CVD and stroke, and the establishment of referral linkages;
• Promotion of the production of affordable drugs to combat diabetes, hypertension, and myocardial infarction;
• Development and support of institutions for the rehabilitation of people with disabilities;
• Research support for: Multispectral population-based interventions to reduce risk factors;
• The role of nutrition and lifestyle-related factors;
• The development of cost effective interventions at each level of care”.

Conclusion:

Many diseases in India, with proper ‘Disease Prevention’ measures can be effectively averted. It is worth repeating that some common measures which can be easily practiced through community initiatives are maintenance of proper hygiene, sanitation, adequate physical activities, moderation in alcohol and tobacco consumption, healthy sexual activities, avoidance of unhealthy food etc.

All the state governments of India through Public Private Partnership (PPP) initiatives with all stakeholders, including the pharmaceutical industry and the civil society, should make the movement of ‘Preventive healthcare’ self-sustainable across the nation. Health being a state subject in India, the role and initiatives of the respective state governments towards this important initiative will be the key determinant of success or failure.

Such a movement, at the same time, needs to be strengthened by appropriate government policy measures and regulations wherever necessary. Pan India roll out of innovative disease awareness campaigns in tandem, highlighting sustainable and effective disease prevention processes will help reducing longer term healthcare cost significantly, thereby translating the well-known dictum into reality, ‘Prevention is better than cure’.

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.