Tag Archives: Tapan

My thoughts on the world IPR day, April 24

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Ushering in the Product Patent Regime in India, effective January 1, 2005, heralds the dawn of a new era… an era that is expected to add speed to the wheels of progress of the nation. The new paradigm vindicates the importance of encouraging, protecting and rewarding innovation to meet the unmet needs of the population. At the same time this change instills new hope in our mind that India will now compete with the bests in the world, more innovatively and effectively, to curve out a significant share of the global economy.

Criticism continues, unfortunately though…

However, it is quite unfortunate that the pharmaceutical product patents that protect today’s innovations and drive research and development to create tomorrow’s life-saving treatments, are under criticism from some quarters. India chose to follow an alternative to Product Patent regime for many years. In 1970, the Government of India amended its IP laws with a clear objective in mind to reduce the prices of medicines to improve their access to the ailing population of the country.

A panacea:

As a result, some drugs were made cheaper. However, the moot question that we need to address now: was it a panacea? While looking back, it does not really appear so. On the contrary, the situation remained as gloomy thereafter, so far as the access to medicines is concerned. After almost four decades of continuation with the above policy, around 65% of Indian population still does not have access to cheaper off-patent medicines against comparative figures of 47% in Africa and 15% in China.

Children still go without routine vaccinations, though the Government has made the primary vaccination programs free in our country, for all. Even in a situation like this, where affordability is no issue, only about 44% of infants (12 – 23 months) are fully vaccinated against six major childhood diseases – tuberculosis, diphtheria, pertussis, tetanus, polio and measles. Moreover, as we know, despite distribution of cheaper generic HIV AIDS drugs by the Government and others mostly free for years, only 5% cent of India’s AIDS patients were receiving any drugs by the end of 2006.

The above two important examples prove the point very clearly that addressing the issue of price alone will not help our country to solve the issue of poor access to medicines to the ailing population of India. Only a sharp focus on rejuvenation of our fragile healthcare delivery system, healthcare financing and rapid development of healthcare infrastructure of the country by the Government or through Public Private Partnership (PPP), will help address this pressing issue.

 

Paving way for innovation…issues of affordability and access need to be addressed differently :

Indian Patents Act 2005 has paved the way for innovation and hi-tech research and development within the country. Contrary to adverse forecasts from some quarters, prices of medicines have not gone up.

However, while medicines play a relatively small role in rising overall healthcare spending including hospitalization, it is important to ensure that individuals with large healthcare expenses have affordable access to required medicines. Thus a good affordable insurance coverage (both Government and Private) available to all Indians belonging to various socio-economic strata, together with the above measures, will help address the key issues of both access and affordability of medicines to all, in a holistic way.

IPR regime…is it more robust in China?

India is continuously compared with China in various parameters both within and outside the country. It is known to all that China is now attracting more Foreign Direct Investments (FDIs), be it Pharmaceutical R&D or Clinical developments of the new drugs. The moot question is why?

India restricts incremental innovation with section 3(d) of the Patents Act, but China has no such restrictive provisions. India does not protect regulatory data of the innovators, but China does. India does not have any patent linkage system with the marketing approval of the generic versions of the patented molecules, but China has put in place such system in their country.

With all these has India been able to improve affordability and access to medicines better than China or as even much as China? No, unfortunately, it has not. In China about 85% of the population has access to medicines, in India the equivalent figure will read as just 35%. Why then are such restrictions in the Patents Act of India? Have the drug prices gone up disproportionately in India post 2005? No… Not really. Unfortunately, the share of voice of the generic industry on these issues being much shriller, the voice of the innovator companies, be it Indian or global, is getting lost in the din, on all these important issues.

Conclusion:

The attack on patents is not a defense of patients or the poor. Such attacks help diverting attention from the core healthcare issues, as mentioned above. Health of our nation will depend on how well these key issues are being addressed by the policy and decision makers. Our country cannot afford to ignore the fact that intellectual property is one of the keys to prosperity of a great nation like India and it should be encouraged, protected and rewarded under a robust patents act of the country for inclusive growth.

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.

Challenges for the Pharmaceutical Industry in the new paradigm – there are more questions than answers

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To get insight into the future challenges of the pharmaceutical industry in general ‘Complete Medical Group’of U.K recently conducted a study with a sizeable number of senior participants from the pharmaceutical companies of various sizes and involving many countries. The survey covered participants from various functional areas like, marketing, product development, commercial, pricing and other important areas.
The study indicates that a paradigm shift has taken place in the global pharmaceutical industry, where continuation with the business strategies of the old paradigm will no longer be a pragmatic approach. Besides this finding, my experience also vindicates that today is not a mega yesterday, just as tomorrow will not be a mega today.
Learning from the results of the above study, which brought out several big challenges facing the pharmaceutical industry in the new paradigm, my submissions are as follows:

Gaining greater market access and increasing pressure of price containment:

The increasing power of payors in the developed world and the interventions of the Government in the developing countries are creating an all pervasive pricing pressure. This critical development together with the issues related to gaining greater market access remain a prime concern for the future.

Better understanding of the new and differential value offerings that the doctors and patients will increasingly look for beyond the physical pharmaceutical products, will indeed be the cutting edge for the winners, in this new ball game.

Questioning the relevance of the current business model:
Top managements of the pharmaceutical companies have already started evaluating the relevance of the current global pharmaceutical business model. They will now need to include in their strategy wider areas of healthcare value delivery system with a holistic disease management focus. Only treatment of diseases will not be considered just enough with an offering of various type medications. Added value with disease prevention initiatives and appropriately managing quality of life of the patients, especially in case of chronic ailments, will assume increasing importance in the pharmaceutical business process.

Greater innovation across the pharmaceutical value chain:
Greater and more frequent incremental innovation across the pharmaceutical Value Chain will be critical success factors. The ability to really harness new technologies, rather than just recognize their potential, and the flexibility to adapt to the fast changing and demanding regulatory environment together with patients’ newer value requirements, should be an important part of the business strategy of a pharmaceutical company in the new world order.

Well integrated decision making processes:
More complex, highly fragmented and cut throat competition, especially in the branded generic market, have created a need for better, more aligned and integrated decision making process across various functional areas of the pharmaceutical business. Avoiding silos and empire building have long been a significant issue, especially for big pharmaceutical companies. Part of better decision making will include more pragmatic and efficient investment decisions and jettisoning all those activities, which are duplications and will no longer deliver incremental intrinsic or extrinsic differential value to the stakeholders.

Customer engagement:
Growing complexity of the prevailing business environment, including most recent change in the MCI regulations for the doctors are making meaningful interactions with the customers and decision makers increasingly challenging. There is a greater need for better management of the pharmaceutical communications channels to strike a right balance between ‘pushing’ information to the doctors and patients and helping them ‘pull’ the relevant information whenever required.

Let me hasten to add, even in the new paradigm, the fundamental way the pharmaceutical industry has been attempting to address these critical issues over decades, has not changed much. To unleash the future growth potential the pharmaceutical companies are still moving around the same old issues like, innovative new product development, scientific sales and marketing, customer focus, application of information technology (IT) in all areas of strategy making process including supply chain, building mega product brands, continuing medical education, greater market penetration skills, to name just a few.

Such responses do ring an alarm bell to me. It is known to many that most of the pharmaceutical companies have been investing in all these areas since long and yet these are the very points being highlighted even in the new paradigm to meet the “Challenge of Change”. The moot question will therefore be, what have all investments in these areas achieved, so far? And why have we not been able to address the needs of the new world order focusing with these tools? More importantly, if we do not address these issues moving ‘outside the box’ and with ‘lateral thinking’ even now, one can well imagine what could the implications be in the times to come?

The future Business Model will need to different:
I believe, the underlying business model of large global organizations focused primarily on developing New Chemical/Molecular Entities (NCEs/NMEs) from initial product discovery through development and commercialization, is unlikely to continue to yield results in the new era. The issue of ‘Patent Cliff’ has already started haunting the research based companies and assuming larger dimensions day by day.
Global pharmaceutical businesses have started evolving beyond patented drugs and including generics to create more diversified and robust healthcare businesses. It is quite evident from the strategies of many larger global pharmaceutical companies that this process has already begun.

Will R&D be collaborative in nature in future?
Currently R&D cost to launch a new patented drug in the market is reported to be around US$ 1.8 – 2.0 billion with accompanying huge risk factors. Thus there is a need to re-evaluate the R&D model of the pharmaceutical companies to make it cost effective with lesser built-in risk factors.
Could there be a collaborative model for R&D, where multiple stakeholders will join hands to discover new patented molecules? In this model all involved parties would be in agreement on what will be considered as important innovations and share the risk and reward of R&D as the collaborative initiative progresses. The Translational Medicine Research Collaboration (TMRC) partnering with Pfizer and others, ‘Patent Pool’ initiative for tropical diseases of GSK and OSDD for Tuberculosis by CSIR in India are examples of steps taken towards this direction.
Surely such collaborative initiatives are not easy but they are not uncommon either, as we witness these, especially in areas like IT. So why cost effective collaborative R&D projects be not initiated to create a win-win situation for all stakeholders in the healthcare space?

Could building pharmaceutical mega brands go beyond just a product for better ROI?
Building brands involve creating equity around an entity that delivers value to the customer, over and above the key functional properties of product. Traditionally, the global pharmaceutical industry has been largely focusing on building mega product brands having specific product life cycle say about ten years, especially for patented products.

Could the core idea of building a mega pharmaceutical brand be substantially different, in future?
I reckon, yes. Instead of investing huge sums in building pharmaceutical product brands with very limited product life cycle (for patented products), a more dynamic, powerful and cost efficient brand building process could well entail focusing on the ‘Corporate franchise’ brands with a mix of both patented and generic products in different price bands for different customer segments within a specific therapy category or disease area.

So instead of consistently creating, building and watching the mega patented pharmaceutical brands grow, mature and die, pharmaceutical companies could well encash the real opportunity to build long term emotional equity into their brands, hopefully without the suffocating NPPA restrictions associated with the current product brands.

Who knows, tomorrow’s list of the world’s top mega brands will not be dominated by the likes of Lipitor, Nexium, Plavix or Advair, but perhaps by quite a different types of mega brands like for example, GSK Vaccines, Sanofi-aventis Endocrinology, Novo-Nordisk Diabetic Care, Abbott Nutrition or Pfizer Cardiac Care.

Serum Institute Vaccines could be considered as one such brand for vaccines as a category, created within the pharmaceutical arena in India, over a long period of time.

Conclusion:
It is indeed quite clear now that the pharmaceutical business models are undergoing a serious re-evaluation in the new paradigm. I get a sense that the change is inevitable due to a variety of trends that are squeezing both sales and margins, posing severe challenges towards R&D, product development, marketing and communications.

As I have deliberated, some kind of solutions are gradually emerging. However, the key questions of how profound will this change be and how well the pharmaceutical companies are prepared to counter these changes, still remain unanswered.

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.

Access to affordable healthcare to 65% of Indian population still remains a key issue even after six decades of independence of the country.

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Despite so much of stringent government control, debate and activism on the affordability of modern medicines in India, on the one hand, and the success of the government to make medicines available in the country at a price, which is cheaper than even Pakistan, Bangladesh and Sri Lanka, on the other, the fact still remains, about 65% of Indian population does not have access to affordable modern medicines, as compared to just 15% in China and 22% in Africa.The moot question therefore arises, despite all these stringent price regulation measures by the government and prolonged public debates over nearly four decades to ensure better ‘affordability of medicines’, why then ‘access to modern medicine’ remained so abysmal to a vast majority of the population of India, even after sixty years of independence of the country?This vindicates the widely held belief that in India no single minister or ministry can be held accountable by the civil society for such a dismal performance in the access to healthcare in the country. Is it then a ‘system flaw’? May well be so.

Poor healthcare infrastructure:

As per the Government’s own estimate, India falls far short of its minimum requirements towards basic public healthcare infrastructure. The records indicate, as follows:

1. A shortage of 4803 Primary Health Centres (PHC)

2. A shortage of 2653 Community Health Centres (CHC)

3. No large Public Hospitals in rural areas where over 70% of the populations live

4. Density of doctors in India is just 0.6 per 1000 population against 1.4 and 0.8 per 1000 population in China and Pakistan respectively, as reported by WHO.

The Government spending in India towards healthcare is just 1.1% of GDP, against 2% of China and 1.6% of Sri Lanka, as reported by the WHO.

Some good sporadic public healthcare initiatives to improve access:

The government allocation around US$2.3 billion for the National Rural Health Mission (NRHM), is a good initiative to bring about uniformity in quality of preventive and curative healthcare in rural areas across the country.
While hoping for the success of NRHM, inadequacy of the current rural healthcare infrastructure in the country with about 80 percent of doctors, 75 percent dispensaries and 60 percent of hospitals located only in the urban India may encourage the skeptics.

PPP to improve access to medicines:

At this stage of progress of India, ‘Public Private Partnership (PPP)’ initiatives in the following four critical areas could prove to be very apt to effectively resolve this issue

1. PPP to improve affordability:

It appears that in earlier days, the policy makers envisaged that stringent drug price control mechanism alone will work as a ‘magic wand’ to improve affordability of medicines and consequently their access to a vast majority of Indian population.

When through stricter price control measures the access to medicines did not improve in any significant measure, the industry associations reportedly had jointly suggested to the government for a policy shift towards public-private-partnership (PPP) model way back in December 2006. The comprehensive submission made to the government also included a proposal of extending ‘concessional price for government procurement’ under certain criteria.

In this submission to the government, the industry did not suggest total price de-regulation for the pharmaceutical industry of India. Instead, it had requested for extension of the price monitoring system of the ‘National Pharmaceutical Pricing Authority (NPPA)’, which is currently working very effectively for over 80 percent of the total pharmaceutical industry in India. Balance, less than 20 percent of the industry, is currently under cost-based price control.

However, the argument of the NPPA against this suggestion of the pharmaceutical industry is that the market entry price of any formulation under the ‘price monitoring’ mechanism is not decided by the government. Hence without putting in place any proper price control/negotiation system to arrive at the market entry price of the price decontrolled formulations, the existing ‘price monitoring’ mechanism may not be as effective, as in future more and more high price patented non-schedule formulations are expected to be introduced in the market.

However, the government seems to have drafted a different drug policy, which has now been referred to a new Group of Ministers for approval. It is worth noting that to make the PPP proposal of the industry effective, the Ministry of Health, both at the centre and also at the state levels, will require to quickly initiate significant ‘capacity building’ exercises in the primary and also in the secondary healthcare infrastructural facilities. FICCI is reported to have suggested to the Government for an investment of around US$ 80 billion to create over 2 million hospital beds for similar capacity building exercises.

Frugal budgetary allocation towards healthcare could well indicate that the government is gradually shifting its role from public healthcare provider to healthcare facilitator for the private sectors to help building the required capacity. In such a scenario, it is imperative for the government to realize that the lack of even basic primary healthcare infrastructure leave aside other financial incentives, could impede effective penetration of private sectors into semi-urban and rural areas. PPP model should be worked out to address such issues, as well.

2. PPP to leverage the strength of Information Technology (IT) to considerably neutralize the healthcare delivery system weaknesses:

Excellence in ‘Information Technology’ (IT) is a well recognized strength that India currently possesses. This strengths needs to be leveraged through PPP to improve the process weaknesses. Harnessing IT strengths, in the areas of drug procurement and delivery processes, especially in remote places, could hone the healthcare delivery mechanism, immensely.

3. PPP in ‘Telemedicine’:

‘‘Telemedicine” is another IT enabled technology that can be widely used across the nation to address rural healthcare issues like, distant learning, disease prevention, diagnosis and treatment of ailments.
Required medicines for treatment could be made available to the patients through ‘Jan Aushadhi’ initiative of the Department of Pharmaceuticals (DoP), by properly utilising the Government controlled public distribution outlets like, ration shops and post offices, which are located even in far flung and remote villages of India.

4. PPP in healthcare financing for all:

Unlike many other countries, over 72 percent of Indian population pay out of pocket to meet their healthcare expenses.

While out of a population of 1.3 billion in China, 250 million are covered by insurance; another 250 million are partially covered and the balance 800 million is not covered by any insurance, in India total number of population who have some healthcare financing coverage will be around 200 million and the penetration of health insurance is just around 3.5% of the population. India is fast losing grounds to China mainly due to their better response to healthcare needs of the country.

As the government has announced ‘Rashtriya Swasthaya Bima Yojna (RSBY)’ for the BPL families, an integrated and robust healthcare financing model for all, is expected to address the affordability issue more effectively.

According to a survey done by National Sample Survey Organisation (NSSO), 40% of the people hospitalised in India borrow money or sell assets to cover their medical expenses. A large number of population cannot afford to required treatment, at all.

Conclusion:

An integrated approach by creating effective healthcare infrastructure across the country, leveraging IT throughout the healthcare space and telemedicine, appropriately structured robust ‘Health Insurance’ schemes for all strata of society, supported by evenly distributed ‘Jan Aushadhi’ outlets, deserve consideration of the government to improve access to affordable healthcare to a vast majority of population of the country, significantly.

Well researched PPP models in all these areas, involving the stakeholders, need to be effectively implemented, sooner, to address this pressing issue.

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 Non-Communicable Disease (NCD) prevention program of the government needs a new thrust to contain the burden of disease in India.

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The 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 percent in 2005 to 26 percent in 2009. It is estimated that chronic illnesses will be the leading cause of both morbidity and mortality by the next decade.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 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.

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 and their family. 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 care 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.

The 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 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 healthcare improvement process of the nation:

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.

Besides, the government should spearhead the paradigm change towards ‘Preventive healthcare’ by including the civil society as a part of this process along with appropriate regulations wherever necessary, generating increased awareness within all concerned and through mobilization of adequate resources. All these will ultimately help all of us to translate 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.

To avoid “Heparin” like tragedy in future, a robust “supply chain integrity and security” system is of critical importance

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Globally the pharmaceutical industry is going through a metamorphosis. The types of changes that are taking place today globally, perhaps has no precedence..

The key drivers of these changes are mainly the following:

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 U.S$ 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, adversely affecting the profit margin

Strategic measures of enormous significance:

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

1. More mergers and acquisitions of various sizes and scales 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 to the pharmaceutical generics space
3. Increasing globalization and greater 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, GSK with Dr. Reddy’s Lab (DRL)
5. Global outsourcing in the ‘Contract Research and Manufacturing Services (CRAMs)’’space, mainly to rationalize costs and deliver the bottom lines, when the top line is under immense pressure.

Demand on all round effectiveness of the “Supply Chain”:
The changing requirements of all types, in sales and marketing, manufacturing and research and development have created a challenging, if not a rather volatile operating environment. In this situation supply chain will increasingly play a key role to ensure that the right product is available at the right place, at the right time, at a right price and following the right process…always.

Outsourcing initiative is not just about cost:
There is at the same time, a new trend emerging for increased outsourcing initiative, especially from countries like India and China. This initiative, which in turn is in the process of making these two countries the key global outsourcing hubs, is definitely not all due to just cost advantages. It encompasses increased integrated value proposition for the customers. Cost is just one of the key factors, others being quality, speed and suppliers’ reliability. Nothing in this value chain is mutually exclusive. Supply Chain will need to go through a set of complex algorithms to strike a right balance between all these vital parameters.

Robust “supply chain integrity and security’ will assume critical importance:
In the days to come by one of the greatest challenges in supply chain management will be to improve the supply chain integrity and security.
An appropriate definition of integrity for supply chains is:

“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.

Are the pharmaceutical companies aligned on this issue?
Though the issue of improving the 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.

RFID is just one component of supply chain integrity:
Globally many Pharmaceutical Companies are getting engaged in improving supply chain integrity, security and patient 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.

Suppliers’ qualification process through stringent ‘supplier audit’ is of critical importance:
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. Only a stringent supplier qualification process will be able to guarantee integrity, safety and the quality of products from the suppliers.

Heparin tragedy, where the supply chain integrity was grossly violated:
Before I conclude, I would like reinforce my recommendation with the example of 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 and thus could not be detected in the case in question.
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.
In today’s deliberations I am sure this issue will be touched upon to ponder over the possible implementable steps to address such future threats effectively.

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.

A global pharmaceutical iconoclast, who sees “Fortune” beyond the creamy top layers of the society … even at the bottom of the Pyramid

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In March 2009 GlaxoSmithKline (GSK) unraveled a path breaking vision, within the global pharmaceutical industry, with the creation of a ‘voluntary patent pool’to spark development of new treatments for neglected diseases of the poorest countries of the world.

The head honcho of GSK Andrew Witty articulated, as reported by Reuters, ‘he feels that this is the right way to help research, especially of tropical diseases like malaria, filariasis, cholera etc. to meet the unmet needs of the poorer population of the world’.

Cares for the poor:
Simultaneously, Witty also announced that GSK will sell its patented medicines in the 50 poorest countries of the world at 25% of their cost in the developed nations and invest 20% of profits made in these poorest countries to help creating and developing local healthcare infrastructure and treatment facilities for the indigenous population.

It appeared to me that this young global pharma CEO is charting the yet uncharted frontiers where there are no footsteps to follow. Witty attained this iconic status when he aired his views without slightest hesitation by admitting openly, “Society expects us to do more in addressing these issues. To be frank, I agree. We have the capacity to do more and we can do more”.

Challenged the global pharmaceutical industry:
The young CEO, to utter surprise of many, further added, “he was challenging the industry to go further to address global health problems by being more flexible on patent protection and pricing in the neediest countries”.

That was March 2009…Came March 2010…

Repeated the firm resolve:
During his visit to India in March 2010, Witty reiterated the same resolve with unequivocal clarity. When a Journalist from “The Economics Times” asked him, ‘There are concerns among some of your global peers about the patent and regulatory environment in this country. Are you concerned with the existing regulatory environment in India?’, Witty replied with his usual conviction and élan as follows:

“I am relatively relaxed with the Indian regulatory environment. The government has made it clear about the direction to have an intellectual property (IP) mechanism and to be TRIPS compliant. Some people are unrealistic and want everything to change overnight. But we should be absolutely realistic about pricing to keep it affordable for India. If someone has the IP right, it does not mean that it should make it inaccessible for lower income people. Over the next 10-15 years India will become increasingly IP defined market.”

Is it a mere ‘lip service?’:
If you ask me, does this leader belong to a different genre? I shall reply with an emphatic ‘yes’. Andrew Witty seems to be indeed ‘walking the talk’ and is understandably quite capable of thinking much beyond of pleasing ‘The Wall Street’ and the likes of it, just with quarter to quarter business performance and ‘guidance’. He thinks about the patients both rich and poor. There are no reasons to doubt this patient-centric noble intent, Nor does it appear to me as a mere ‘lip service’.

One can interpret a ‘one-off statement’ made by any global pharma CEO in a way that one would like to. However, repetition of the same statement time and again in different counties possibly reflects nothing but firm resolves of a young visionary, determined to translate the same into reality with unprecedented courage.

Conclusion:
This iconic CEO, I reckon, is doing no charity or philanthropy with his path breaking vision, as those are not certainly the purpose of any business. Neither should one do charity or philanthropy with shareholders’ money and without their clear consent. Andrew Witty, in my view, perhaps is in the same page as with the management Guru C.K. Prahalad, who first postulated, now an oft repeated hypothesis, ‘The fortune at the bottom of the pyramid’.
Witty, as I have been witnessing, has already demonstrated his prowess with the traditional pharmaceutical global business model, in a comparative yardstick. Now professionally equipped with a strong pharmaceutical marketing background, honed over so many years, I am sure, Andrew will succeed even more in curving out a lion’s share of the global pharmaceutical business for his company, in the long run, creating a win-win situation for much over six billion global people, including a vast majority of the ailing, poor, neglected, hungry and marginalized population of the world.
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.

Bt Bringal…health and food safety…agricultural independence…biodiversity, are all intertwined

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Bacillus Thuringiensis (Bt) Brinjal has now become a subject of intensive debate for various important reasons. Bt Bringal is a genetically modified strain of Brinjal, developed by the premier seed company in India Mahyco in collaboration with the American major Monsanto. The main claim of such seed varieties is improving yield by protecting the crop from the pests.
The key concerns related to products like Bt Brinjals are in the following areas:

1. Health and Food Safety

2. Dependence on overseas companies year after year for agricultural products

3. Compromising ‘biodiversity’

4. Effectiveness of Bt products

Health and Food Safety:

The main focus of the debate revolves round the health and food safety concerns with such biotech food products. Environmentalists point out that the genetically modified foods while fed on rats have already shown fatal kidney and lung disorders.

Gilles-Eric Seralini, a French scientist has opined that the tests conducted by Mahyco for Bt Brinjal are unsustainable and would raise very serious health and food safety concerns.

Adverse safety results with Bt cotton, like respiratory tract related problems, skin allergy, immunological disorders etc., from many countries of the world further aggravate the health and food safety concerns with Bt Brinjal. Many experts have opined, as mentioned above, that such disorders could lead to even death with long term use of these products. It will perhaps be imprudent on the part of the civil society to take such ‘public health’ concerns lightly.

Alleged bias by GEAC:

Besides, health and food safety concerns many activists feel that the initial approval of Bt Bringal by the Genetic Engineering Approval Committee (GEAC) raises a suspicion of bias towards overseas Bt seed manufacturing companies.

Could it lead to Agriculture dependence on overseas companies?

Another important point that needs to be deliberated by all concerned is the impact of such technology producing ‘terminator gene’. Many apprehend that such a move by India could pose a threat to the agriculture of the country over a period of time, with Indian farmers buying these costlier varieties of seeds from the overseas companies year after year and being dependent on them for the same.

Since India does not recognize patents on life-forms, farmers will be required to pay a type of royalty to the manufacturer, usually known as ‘Trait Fee’. Such fees used to be levied for Bt cotton seeds. However, on this type of fees, in response to a petition filed by farmers in Andhra Pradesh against an international manufacturer and supplier, Monopolies and Restrictive Trade Practices Commission (MRTPC) gave its ruling in 2006, which is as follows:

“The trait fee being charged by the respondent not only imposes unjustified costs on the farmers by way of manipulation of prices but is also unreasonable in view of lack of competition.”

Many experts feel that such anti-competitive practices involving food products could lead to a different type of dependence on the overseas suppliers of Bt seeds, even if such products are found safe.

Further, concerns related to the control of such seeds and the lack of investment in the public sector for biotech research in this area should be urgently addressed.

The concern related to ‘Biodiversity’:

There is also another important concern related to ‘Biodiversity’. It has been reported that around 2500 varieties of Brinjal are available in India. Brinjal being a plant resulting from cross pollination, entry of Bt.Bringal could lead to genetic contamination affecting existence of many such locally grown varieties raising the contentious issue of ‘biodiversity’.

In the context of Bt Bringal, Dr. Manmohan Singh, the Prime Minister of India has recently issued a statement, as follows:

“It was agreed that biotechnology is an important option for higher agricultural productivity and ensuring food security. At the same time, we must ensure that it has no adverse effects on human and animal health and bio-diversity.”

“Keeping this in mind, the government will soon be moving forward in setting up a National Biotechnology Regulatory Authority which will inspire confidence and stimulate public and private investment in biotechnology.”

If ‘Food security’ is the issue, why choose Bt Brinjal?

However, if Bt products will help the nation to address the ‘food security’ issue, the question that will logically emerge, “why then Bt Brinjal?”

As far as I know, India is one of the largest producers of Brinjal in the world with so many varieties of it and there is no shortage of Brinjal in the country either. Thus ‘Food Security’ could hardly be an issue, at least in this case.

Effectiveness of Bt products:

We all have read the media reports related to many incidences of mass suicides by Indian farmers due to crop failures with Bt Cotton. The effectiveness claimed by the manufacturers of Bt cotton is now shrouded with doubts. The following report from ‘The Times of India’ dated March 7, 2010 vindicates this point:

“Bt cotton failed to thwart pests in Gujarat”. Monsanto also concedes, “During field monitoring in 2009, the Bt cotton variety used in four Gujarat districts – Amreli, Bhavnagar, Junagadh and Rajkot was found to attract the pink bollworm, a major pest that attacks cotton plantations”.

Such reports further strengthen the argument of the Environment Minister of India, Mr. Jairam Ramesh that Bt seed varieties should be evaluated with utmost care and precision before nationwide operationalization, for the reasons mentioned above.

Conclusion:

Be that as it may, I believe that uncontrolled entry of Bt products should NOT be encouraged in India without:

- Proper knowledge of their serious adverse effects on human and animal health on long term consumption

- Having scientific proof on their long term effectiveness

- Protecting agricultural independence of the country

- Encouraging indigenous biotech research in this field

- Satisfactorily addressing the concern related to ‘biodiversity’ of the nation.

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.

The Union Budget 2010-11…the issue of improving access to healthcare…encouraging innovation… and beyond

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The Primary role of the pharmaceutical industry in India, like in many other countries of the world, is to make significant contribution to the healthcare objectives of the nation by meeting the needs of the ailing patients through improved access to modern medicines.

This role could be fulfilled primarily in the three following ways through Public Private Partnership initiatives:

1. By improving the healthcare infrastructure and the healthcare delivery systems
2. By creating a favorable echo system for developing newer innovative medicines through R&D initiatives in the country
3. By taking policy measures towards a robust healthcare financing system for all strata of our society

Improving access to modern medicines:

In the Union Budget 2010–11, the Finance Minister has proposed an increase in allocation towards healthcare from Rs. 19,354 Crore to Rs. 22,300 Crore. It is expected that a significant part of this increased allocation will be utilized in improving healthcare infrastructure and delivery systems, in the country.

Moreover, extension of ‘Tax Holiday’ for hospitals set-up in rural areas from 5 to 10 years, is expected to encourage development of rural healthcare infrastructure. The Finance Minister has also proposed that ‘Tax Holiday’ will be available for hospitals set-up even outside rural areas.

The proposal for extension of health insurance to NREGA beneficiaries is also expected to have a positive impact in improving access to modern medicines within this sector of the population.

It is my strong belief that currently, improving access to healthcare in general and medicines in particular along with encouraging innovation, should be the top-priorities of our policy makers. High incidence of mortality and morbidity burden in a country like ours can only be addressed through such priority measures. It is believed that Indian Pharmaceutical Industry would always remain committed to actively support all such efforts from all corners to help achieving this objective.

Encouraging innovation:

The budgetary proposal of enhancement of scope of weighted deduction on expenditure incurred on in-house R&D to 200% and the same on payments made to national laboratories, research associations, colleges, universities and other institutions for scientific research to 175%, are welcome steps.

However, in my view only the above steps are not adequate enough to properly encourage innovation within the country. Ongoing efforts in Research & Development (R&D) would require a robust national policy environment that would encourage, protect and reward innovation. Improving healthcare environment in partnership with the Government remains a priority for the pharmaceutical industry in India.

Despite progress made over the past decades in developing new medicines for some acute and chronic illnesses by both the Indian pharmaceutical companies and R&D organizations, innovation, like in other developed countries, still remains critically important in the continuous and ever complex battle between disease and good health in India.

Other encouraging budget proposals:

The following proposals of the Finance Minister are also expected to benefit the Industry:

- An annual Health Survey to prepare the District Health Profile of all districts in 2010-11

- Uniform concessional basic duty of 5% for all medical appliances and exemption of import duty from specified inputs for the manufacture of orthopedic implants, are good initiatives.

- Reduction of Corporate surcharge from 10% to 7.5%, though corporate Minimum Alternate Tax has gone up to 18%

- Tax incentives for the business of setting up and operating “Cold Chain” infrastructure, which is an integral part in the logistics for vaccines and many biotech products

- Under section 10B, extension of sunset clause is expected to benefit the Export Oriented Units (EOUs)

Adverse impact on affordability:

Some steps taken in the Union budget may have major impact on the Indian Pharmaceutical Industry, which are as follows:

• Goods and Service Tax (GST) coming in April 1, 2011 and Minimum Alternate Tax (MAT) hiked to 18% could prompt restructuring of ‘supply chain’ of many companies

• Increase in fuel prices and withdrawal of ‘Service Tax’ exemption on transportation of goods by rail, could make pharmaceutical products more expensive.

The Union Budget 2010–11, which has been largely hailed as a good budget across the industry, unfortunately does not propose much in terms of major fiscal and policy measures for the pharmaceutical industry.

Conclusion:

Be that as it may, going beyond the budgetary expectations, the pharmaceutical industry in India should keep focusing on good corporate governance. This encompasses adherence to high ethical standards in clinical trials and in promotion of medicines, regulatory and legal compliance, being harsh on corrupt practices, addressing all issues that support good healthcare policies of the Government and takes care of the healthcare needs of the common man through inclusive business growth.

It is obvious that the Pharmaceutical Industry alone will have a limited role to play to address all the healthcare issues of the country. Important stakeholders like the Government, Corporates and the civil society in general must contribute according to their respective abilities, obligations and enlightened societal interests, towards this direction.

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.