Malaria and other Infectious Diseases – India’s Perspectives
at the Geneva Roundtable on Health-related MDGs,
17th September 2009

1. Human civilization is at a running battle with infectious diseases.  Across the ages, these diseases have emerged, greatly affected human population, mutated and sometimes been controlled.  The black-death, one of the deadliest pandemics in human history, struck in the Europe in the 14th century and caused some 75-200 million deaths.  Spanish influenza pandemic of 1918-19 affected almost one-third of the world’s population and caused deaths of upto 50-100 million.  The current series of pandemics be it SARS, Avian Flu, or the current Swine Flu have made it all the more relevant the dangerous impact of infectious diseases on human population.

2.       In today’s modern world, there are some obvious factors that have enhanced the impact of infectious diseases on human population.

• Globalization:  Today’s world is extremely inter-dependent, improved transportation has facilitated cross-border movement.  The World Tourism Organization estimated that around 924 million tourists traveled to foreign countries in 2008.  This was an increase of 16 million over 2007 and is expected to reach 1.6 billion in 2020.  (Tourism revenues generated US$ 856 billion in 2007, roughly 30% of the world’s export of services.)  Such trans-continental travel facilitates movements of infectious disease vectors and their economic consequences are therefore equally global.

• Accelerating urbanization:     At the turn of the 20th century, only 5% of global population lived in cities.  Today, that figure is almost 50% and is expected to reach 70% by 2050.  Increasing urbanization, particularly in poor countries, due to the density of population, weak health systems, poor infrastructure, inadequate sanitation, increase the spread of infectious diseases.

• Modern medical practices:   Misuse of antibiotics is helping generate more resistant and powerful disease strains.  In fact, drug resistance has become a serious public health problem leading to increasing mortality rates and rising healthcare costs.  Just in the case of malaria, it is estimated that around 300 million or more drug resistant malaria cases surface every year.  So is the case in TB, cholera, pneumonia, dysentery and typhoid.

• Global warming and rising temperatures:   These will also have implications for the spread of infectious diseases as disease vectors will proliferate exposing new regions and peoples to malaria, sleeping sickness, dengue fever, yellow fever and other insect-borne illnesses.

• Public health burden:   Infectious diseases are thus a major public health issue for both developed and developing countries.  The difference is for developing countries, the human cost is immediate and severe in terms of infant mortality, maternal mortality, diminished economic productivity.  As infectious diseases move to the developed country, there will be an increasing threat, particularly from the drug resistant varieties.

 

3.       Developing countries carry a “dual burden of the disease”.  In addition to infectious diseases, as in the case in the developed countries, changing life styles enhance the threat of chronic non-communicable diseases also.  Such countries, therefore, face a double whammy.

 

4.       Consequently, disease control is often crisis-driven with public health agencies and Government’s reacting to epidemics and sparing very little resources to prevent them.  Therefore, we have to recognize that in the long run, prevention is our most effective weapon against infectious diseases followed by control of any emergence and spread of infectious diseases.  To achieve this, we need to:

 

• Expand coverage of basic public health measures, including vaccines, antibiotics and medicines.  We need to expand access to basic healthcare and medical services and raise public awareness of the threats of these diseases.
• Improve the global health monitoring system by strengthening surveillance, improving rapid diagnosis, communication and response to provide early warning to health officials for creating an efficient response set up.

5.       Neglected diseases:    Many of the infectious diseases are neglected.  Look at the statistics:

 

• 300 million children die every year from vaccine-preventable diseases (such as  …………….  Measles, diphtheria, hepatitis, meningo coccus, influenza, polio, rabis, tetanus, rubella).
• One billion people suffer from some type of neglected tropical diseases (such as  …………….. around 13 neglected diseases, mostly parasitic, spread by vectors, eg. blinding trachoma, lymphatic filariasis, leishmaniasis, chagas disease, onchocerciasis). 

 

• Four million healthcare workers are needed to fill the healthcare gap in developing countries.
• Malaria is the leading cause of mortality in children under five in Africa and constitutes 10% of the continent’s overall disease burden.

 

• Only one in five with HIV/AIDS receives the medicines they need.
• It is estimated US$ 6-10 billion will be required over the next 10 years to develop projects for neglected diseases.

 

• Only 10% of the global R&D is devoted to conditions accounting for 90% of the global disease burden.

 
The crucial thing to remember here is that the methods of preventing and treating most infectious diseases are well-known.  However, lack of money, personnel and infrastructure often combine to prevent the use of these methods.

 

6.       What is India doing:   The Government has a national plan to strengthen health systems, promote health research and improve human resources while increasing budgetary support for all these measures. 

 

7.       There are national programmes in place for tackling the burden of infectious diseases including those of malaria, filaria, leprosy, kala azhar.

 

8.       India implements a national vector-borne disease control programme under the Ministry of Health as the national nodal agency for prevention and control of the major vector-borne diseases of public importance.  Mainly malaria, filaria, kala zahar, Japanese encephalitis and dengue hemorrhagic fever are covered.

 

9.       India has allocated US$ 110 million over three years to upgrade its disease surveillance network.  This will also include modernizing the 100 years old Communicable Diseases Institute in New Delhi into a National Centre for Disease Control (NCDC) along the line of the US Centre for Disease Control and Prevention in Atlanta.  The wake-up call for us came in the 1994 with the outbreak of pneumonic plague in India which caught us un-prepared.  This World Bank collaboration project, launched in 2004, is creating a backbone for disease surveillance systems which will cover all the 600 districts in the country, include disaster surveillance officers and rapid response teams in each district and 24/7 satellite communication links with Delhi.  The NCDC will concentrate on South and South East Asia as well.       

 

10.     In October 2007, the Government has created a new Department of Health Research with the intent of moving research to the centre-stage of health development which will orchestrate an effective health research response towards emerging infectious diseases.

 

11.     Under the integrated disease surveillance project, the Indian Council of Medical Research (ICMR) is strengthening its network of institutes devoted to specific infectious diseases while establishing a zone of regional centres in areas of emerging infections such as North-East of the country, the Andaman Islands etc.  Surveillance will form an important tool for control of infectious diseases.  A chain of Bio Safety Level-3 (BSL-3) laboratories has been set up with the National Institute of Virology’s microbial containment complex at Pune at the apex, which will soon to be upgraded to  BSL-4 category.  Rapid molecular tools for virus identification have also been installed.  Microbial repositories for organisms of public health importance have also been created to make available strains and viruses to research organizations.  A Masters course in Virology has also been started in Pune with the plan to create regional centres of excellence in viral diseases throughout the country.

 

12.     The national health policy of the Government aims to improve essential healthcare services by boosting public healthcare to 2% of the GDP by 2010.  It also aims to decentralize to the regional and State level powers for conducting health programmes to guarantee that all groups benefit from adequate treatments.  There will be greater engagement with private sector through partnerships as 80% of our health infrastructure is in the private sector.

 

13.     A new Pharmaceuticals Department has been created for promoting drug research, boosting public-private partnership models, facilitating education in drug research, development of infrastructure, manpower and skills for the pharmaceutical sector.

 

14.     Government has started its JAN AUSHADI campaign to create generic drug stores across the country and already 40 of them are planned to be opened by the end of the current financial year.  These stores will make available unpatented generic drugs at affordable prices to ensure access to medicines for all.

 

15.     To promote R&D, the Government along with the private sector is planning to invest US$ 1-2 billion a year to make India one of the top five global pharmaceutical innovation hubs by 2020.  This will be facilitated through deliberate actions on multiple fronts which include infrastructure development, financial incentives to incubate innovation and shaping a favourable regulatory environment.  The idea is to find cost-effective cure for diseases endemic in India with a target of discovering in India one out of  5-10 drugs discovered worldwide by 2020 and increasing the contributions of the pharma industry to the Indian GDP by around US$ 20 billion by 2020.

 

16.     The Government has also approved a major health insurance scheme for the workers of the unorganized sector which also include those families below poverty line for coverage within a period of five years.

 

17.     What does the developing world need from big pharma:

• Drastic reduction of prices of medicines, sharing of patents for molecules and compounds particularly those that can ameliorate diseases affecting the developing world.    

  

• Investment in health infrastructure.
• The business model of pharmaceutical companies depends on recouping their outlay on R&D by selling an end-product at profit.  But the use of pure market economics will exclude patients who cannot pay with more than 3 billion people surviving on less than US$ 2.5 a day.  Affordability of medications has to become an important issue for the big pharma to address and redress.

 

• Patent pooling to promote manufacture of cheaper generics is no doubt a taboo for pharma companies but nevertheless has to be encouraged.
• Making use of orphan drugs is also very important.  The example that comes to mind is what the Institute of One World Health has done in India for treating visceral leishmaniasis (kala azhar) through use of the peromonycin injection cure.  Orphan drugs typically treat illness that are rare in the developed world, yet can make remarkable improvements in public health in the developing world.

 

• There is need to close the 10/90 gap where only 10% of the health R&D is applied to 90% of the world’s health problems.  There has to be increased attention paid to global public health and neglected diseases.  Resource mobilization for research, transfer of drug development technology and capacity-building in poor countries is essential.  Otherwise, the 10 million people who die globally each year from diseases that are treatable with existing drugs will continue to do so. 

 

18.     Access to medicines:      Equitable access to safe and affordable medicines is vital to the enjoyment of adequate standards of life by all.  States, therefore, have a commitment for improving the delivery of and access to medicines by overcoming barriers to access.  The access to medicines debate does involve an intricate interplay between macro-economic development, disease pattern, healthcare needs, development and health policy, health system infrastructure, pricing, rationale use of drugs and adequate and sustainable funding. 

 

19.     While the fundamental aspects of healthcare provisions are the responsibility of Governments, pharmaceutical companies need to play a greater supporting role to improve patient access to medicines.

 

20.     The WHO estimates that one-third of the world’s population lacks regular access to essential drugs and this estimate rises to over 40% in low income countries and over 50% in the poorest countries of Asia and Africa where infectious diseases such as TB, malaria and AIDS are leading causes of death.  Drug prices and patents are some of the obstructions to access along with inadequate health services, lack of healthcare personnel and infrastructure in these countries.  

 

21.     Access to medicines is a very critical component in the progressive fulfillment of the right to health and therefore the right to life.  Only through equitable access can non-discrimination and equality in treatment be enabled.  Therefore, the right to access needs to be reiterated and implemented if the right to health has to be fulfilled by States.  Although the majority of WHO’s essential medicines are off-patent and subject to generic competition, access to newer on-patent drugs is also needed to combat infectious diseases, expand immunization programmes and address non-communicable diseases.  Achieving the health-related MDGs including reducing child mortality, improving maternal health and combating infectious and poverty-related diseases demand universal access to existing and new affordable treatments for diseases, particularly in the developing countries.

 

22.     In this context, the access to medicines index can become an interesting innovation towards enabling the major pharmaceutical companies to enhance access to vital medicines in order to promote global health.  It will hopefully facilitate transparency in industry practices, promote corporate social responsibility in respect to healthcare and provide guidance to companies to improve access to medicines.  

 

23.     An interesting use of ICT technology in the context of access to medicines was the action of the Kenya-based Health Action International which used SMS texting with online mapping technology to greate a picture of stock-out of medicines across some countries.  Use of this technology is an interesting tool, both for Governments and for pharmaceutical companies, to address national deficiency in availability of essential medicines.    

 

24.     Global health partnerships:  Increasingly global partnerships, including public-private collaborations that transcend national boundaries, are providing a useful mechanism to tackle the major diseases in the developing world.  Be it the Global Fund to fight AIDS, TB and Malaria or the Global Alliance for Vaccines and Immunization or UNITAIDS, these collaborative partnerships between multiple organizations are generating resources and focusing attention to address specific diseases.  Similarly, private foundations, be it the Melinda & Bill Gates Foundation and their efforts in vaccines, immunization and Global Malaria Programme or the Clinton Foundation and its efforts in the area of HIV/AIDS and affordable second-line anti-retroviral therapy for HIV/AIDS and tuberculosis or the Carter Foundation’s work in the area of neglected tropical diseases point to the utility of partnerships and private philanthropy.  Similarly, the role of global NGOs including MSF and Oxfam and their campaigns for access to medicines and healthcare are indeed significant contributions to global solidarity.

 

25.     In India too, the Indian Business Alliance’s Stop-TB campaign has been a useful initiative in the private-public partnership approach and has had success in treating TB infected individuals in India.  Similarly, in leprosy treatment through multi-drug therapy, HIV/AIDS, polio eradication and immunization programmes, Government’s efforts have been greatly bolstered through private participation.  Similarly, the Public Health Foundation of India involving the Bill Gates Foundation, the Harvard School of Public Health, the All India Institute of Medical Sciences and others will influence public health education, research and policy in India and focus on India’s most urgent health problems.  After all, 93% of all hospitals, 64% of all hospital beds, 80-85% of doctors, 80% of out-patients and 57% of in-patients are estimated to be in the hands of private sector in India and the Planning Commission is looking at the prospect of mainstreaming PPP between the Government, private sector and non-profit sector in healthcare.

 

26.     TRIPS and TRIPS flexibilities:       The WTO Agreement on TRIPS impacts on access to medicines, both by globalizing minimum standards of patent protection and by providing key flexibilities for bypassing IP barriers to protect public health.


27.     TRIPS-related legislation will have an impact on the price and availability of newer drugs.  Since 2005, India has incorporated TRIPS into its patent legislation.  Therefore, the scope of generic drug production of new drugs is limited.  While the 2001 Doha Declaration and the 2003 WTO decision categorically lay down the provision for flexibilities to enable developing countries to ensure access to healthcare and take measures to protect public health, this has not always been done.  Countries lack sufficient capability and capacity to manufacture medicines of their own and, therefore, cannot make use of compulsory licensing.  Similarly, developing countries often lack the technical knowledge and advice to incorporate legislative changes for the legal use of TRIPS flexibilities and, of course, many developing countries come under pressure from the developed world to introduce the so-called TRIPS-plus legislation in bilateral trade agreements.  Therefore, there is an urgent necessity to see how TRIPS can accord primacy to public health and enable countries to fulfill their right to health obligations when facing intellectual property barriers.

 

28.     Concluding Remarks:   Managing infectious diseases is a major policy issue that transcends national boundaries.  It affects both developing and developed countries.  The immediate burden of infectious diseases is levied on those who can least afford it.  Africa and India both suffer significant population loss from infectious and parasitic diseases.  Approximately five million people in Africa and two million people in India, mostly children and young adults, die because of these diseases.  Together, they account for 70% of all infectious diseases deaths worldwide and 13% of all deaths worldwide.  These are staggering figures and need to be addressed if global solidarity has to acquire true meaning.  

 

29.     Health improvement in India while significant has not kept up with our economic growth rates.  The poor in India face high out of pocket payments for healthcare, a significant burden of infectious diseases and a rapidly increasing burden on non-communicable diseases.  Public spending will increase but more is required.  (We hope that 1% of GDP increase in public health expenditure could save as much as 480 million healthy years of life.  That translates to around 0.2% per capita).  We recognize that infectious diseases is a significant risk factor for our growth particularly if we are to sustain and attain 8-10% growth rate.  We are therefore determined to address this issue seriously. 

 

30.     A word on the contribution of Indian pharmaceutical industry is necessary here.  India carries the label of being the pharmacy of the developing world, as some organizations have pointed out.  This is largely due to the efforts of the Indian pharma industry.  Take the case of malaria.  In the ACT therapies (Artemesinin Combination Therapy) retail costs in India of combinations such as (chloroquine-primaquine: US$ one, quinine-primaquine: Rs.250 (US$ five), mefloquinin-artemesinin: Rs.450 (US$ nine) which translated into US$ 5-10 per person per treatment at retail prices.  This has contributed for the fall in malaria mortality in India by over 85% in the last five years.

 

31.     The Indian company Advinius Therapeutics Limited in collaboration with the Genzyne Corporation and Medicines for Malaria Venture (MMV) is developing new anti-malarial agents.  Similarly, Ranbaxy in collaboration with MMV is developing the synthetic peroxide anti-malarial drug to supplement older drugs and prevent drug resistance.  Four Indian and two Chinese companies along with the Clinton Foundation will cut the price of a key malarial – ACT drug.

 

32.     Indian pharmaceutical industry has played a big role in providing good quality and cheap generic drugs not only in the country but also to other developing countries.  It has a 14% share of the US$ 57 billion worth generic market.  We have advantage of cost-competitiveness, experience in reverse engineering, availability of skilled scientific and engineering personnel and the capability to produce basic raw materials for a wide range of important drugs.

 

33.     India has close to 100 manufacturing facilities approved by the US FDA and the UK Medicines and Healthcare Regulatory Authority and around 50% of those were commissioned in the last three years.  That is why we see that more global pharma companies will be using India for offshore drug production, dedicated R&D and other medical services.  Frost & Sullivan estimate outsourced production market in India to reach US$ 6.5 billion in 2013.

 

34.     India also plays an important part in the global API market (Active Pharmaceutical Ingredient).  The API output value from India was US$ 4.1 billion in 2007 showing a growth rate of over 18% between 2003 and 2007.  India ranks 4th in the world in terms of API output.  This satisfies over 90% of Indian domestic demand while export of API from India is projected to reach US$ 12.75 billion in 2012.  Indian companies thus have the distinction of developing cost-effective technologies for manufacturing bulk drugs and intermediates that conform to global standards.

 

35.     India exported drugs worth US$ 4.15 billion in 2007-08 while the domestic pharmaceutical market was estimated to be US$ 10.76 billion in 2008.  According to the Ministry of Commerce, domestic investment in the pharmaceutical sector is estimated at US$ 6.31 billion and FDI into the country in this sector was US$ 1.43 billion upto December 2008.  The Indian pharma industry will see growth in the coming years as consumer spending on healthcare will increase from the present 7% of GDP in 2007 to 13% of GDP by 2015.

 

 

********