Healthcare is a noble mission

I am indeed delighted to participate in the inauguration of International Conference on Equity and Access to Medicine organized by Research and Information System (RIS) at New Delhi. My greetings to the economists, educators, social scientists, societal reformers, doctors, members of the pharma community and other distinguished guests participating in this international conference. I particularly greet the delegates coming from various parts of the world whose knowledge will definitely enrich the participants of this conference. When I am in the midst of this unique gathering, I would like to talk on the topic "Multi-dimensions of Healthcare".

Friends, recently I have received a copy of National Formulary of India 2010 (NFI) evolved by (IPC) Indian Pharmacopoeia Commission. NFI is indeed a beautiful mission. It gives the diagnoses of the disease and the type of medicine to be administered along with the doses. I would suggest NFI should be put in "on-line" which will benefit the patients and the professionals. I would also suggest that NFI could give the details of approved alternative medicines from Ayurveda, Unani, Siddha, Homeopathy, Yoga and Naturopathy which pertains to our native knowledge. This would make NFI more comprehensive and contribute towards holistic medicine in a cost effective manner. Though, NFI 2010 is a fantastic work, I have one comment. NFI does not provide caution about shelf-life of medicines, particularly since many of the Pharma companies do not provide the date of expiry in bold letters. The combined action by the IPC in their later addition will definitely make an impact towards providing cost effective healthcare to the needy patients.

In the international presence of experts in the field of medicine, I thought of sharing Indian experience aiming bringing down the cost of new drugs, particularly TB and Malaria. This experience of India relates to healthcare domain through Open Source movement based on the new and innovative approach in soliciting the contribution from the young minds across the world.

The Open Source Drug Discovery (OSDD) programme is a CSIR led team India consortium with global partnerships, with a vision to provide affordable healthcare to the developing world.
Market forces discourage research- based pharmaceutical companies from developing drugs for infectious diseases like Tuberculosis (TB), Malaria, and Leishmaniasis (Kala Azar) that predominantly affect the developing world. Without a market attractive to global pharmaceutical industry, it would be naïve to expect drug discovery for infectious diseases to become a lucrative standard business model. In the wake of the failure of market forces we need to explore new models of drug discovery. This is where OSDD offers a promising new model.

OSDD has chosen TB as the first target disease. The current TB therapy was developed in the 1960?s. The therapy is a combination of four drugs which has to be administered under observation of the physician for six to eight months. In India, an estimated 370,000 deaths due to TB occur each year. This amounts to over 1,000 deaths a day, or 2 TB deaths every 3 minutes. This disease which affects mostly our poor is a huge problem for the nation. OSDD aims to discover better and more effective drugs for TB by involving large number of researchers based on the open source philosophy that more eye balls make all bugs shallow.

The Open Source approach has been successfully adopted in software and collaborative approach is known in science. OSDD?s effort to do discovery in the open with the aim of collaborate, share, discover makes it highly participative. It enables manifold expansion of resources for research.

Launched on 15 September 2008, OSDD has more than 4500 registered users from over 100 countries and more than 150 projects on TB drug discovery. A large part of the funding of OSDD comes from the commitment of the Government of India of Rs 46 crore for the 11th plan period. OSDD offers a model of open innovation in pharmaceutical research as it concurrently carries out research in many areas of drug discovery.

With many eminent scientists playing an active role, OSDD also has a large number of youngsters who want to do science and make a difference. From remote regions of the country they get connected through the website and network with peers to solve challenging problems in drug discovery.

One of the OSDD project which has made a big impact is the collaborative annotation of the bacteria causing TB, namely Mycobacterium tuberculosis (Mtb). The scientific purpose was to improve the understanding of the biology of the organism to develop better tools to tackle the pathogen. It was done through a collaborative project involving about 800 researchers from India and abroad. They finished the task of re-annotation which involved reading of published literature from 1960 onwards and capturing the data in those papers. The task, which some experts estimated would take 300 man years was accomplished in four short months; amply demonstrating the power of collaborative research and what youth-power can do, given the right platform and guidance.

Enthused by this result OSDD is currently pursuing a collaborative Chem-informatics programme where about 400 researchers are participating.

All such top end research calls for a highly sophisticated collaborative platform. M/s Infosys has created a web 2.0 collaborative platform using open source tools in collaboration with OSDD for TB research. This was done pro bono by Infosys showing their commitment to support a scientific project seeking to develop drugs for the diseases that affect predominantly the poor.

OSDD provides an alternative way of looking at Intellectual Property as a tool of research. In the wake of failure of the patent driven model for drug discovery, OSDD treats its entire work as a collective property of the community while each contributor gets credit of the work done though a micro attribution system. The drugs that come out of OSDD are promised to be manufactured on a non exclusive basis, like a generic drug, removing the monopoly attached to drug production. This will ensure that the drugs are available and affordable in the developing world. OSDD has innovative ways of looking at patents as a concept. It is currently working on optimizing a patented molecule as a drug. OSDD plans to use this patent to ensure the drugs are affordable in the market by ensuring non exclusive licensing. This is an innovative way of using patents to the benefit of poor patients.

CSIR has given a clarion call to all ignited minds, be they students, researchers, scientists, academicians, doctors, software professionals, traditional healers or industry experts to join the battle against infectious diseases by joining OSDD.

This youth movement of OSDD can be extended to willing nations for development of generic medicines through a world knowledge platform which will bring the cost effective solution to medicare. As an example of World Knowledge Platform, another experience of India Pan-African e-network as an International social responsibility project.

Since I am in the midst of international audience, I would like to mention about an international social responsibility project Pan-African E-network being executed by Govt of India in partnership with 53 African countries.

During the year 2003-04, I visited African countries such as Sudan, Tanzania, Zanzibar and South Africa. I addressed the Pan African Parliament on 16 Sept 2004, at Johannesburg, South Africa which was attended by Heads of 53 member countries of the African Union. Based on my study of the communication, healthcare and education needs of the African countries, I proposed the concept of Pan African e-Network for providing seamless and integrated satellite, fiber optics and wireless network connecting 53 African countries. This Indian initiative was accepted by the Pan African Parliament.

As part of the project, 12 universities (7 from India and 5 from Africa), 17 Super Specialty Hospitals (12 from India and 5 from Africa), 53 tele-medicine centers and 53 tele-education centres in Africa are being connected. So far 34 countries have been connected and more than 300 sessions of continuing medical education programmes have been conducted by 6 Super Specialty Hospitals of India to the doctors of African nations. Two universities have already conducted higher education programmes and completed one MBA course, and continue to provide professional education to the African countries, 6 hospitals are conducting tele-medicine programmes to 34 countries. The rest of the 19 countries will be connected this year and Pan African e-network programme will be completed.

I consider Pan-African e-network programme is a good example of fulfilling the international social responsibility through cooperation among nations. It is also a good example of how nations can share their core competence and enrich each other in knowledge and connectivity including healthcare benefits, particularly free diagnosis, free training, and free medical education.

When I study the problem of healthcare in different parts of the world, certain thoughts came to my mind which I would like to share with you. Every country has a specific combination of sanitary conditions, nutrition, life style and disease pattern. Naturally, the research has to be nation specific and also in certain cases region specific, so that we can provide an integrated solution to the prevention or cure of a particular disease in the most cost effective way. In this connection I would like to talk to you about a strategy adopted in a beautiful hill region in India which I am fully familiar with.

On 19th October 2002, I participated in the launching of a Mobile Clinic and Research Centre in Uttaranchal. This effort was piloted by the Technology Information, Forecasting and Assessment Council [TIFAC], the Government of Uttaranchal, Birla Institute of Scientific Research and many other agencies. After thirty two months of its operation, I found this mobile clinic has been used in six districts of Uttaranchal and treated nearly 1,50,000 patients during this period. Among the patients treated, 48% belong to the below poverty line category. They have taken 30,000 ultra sound, 16,000 X-rays, 5000 ECGs and nearly 60,000 lab tests. The mobile clinic has documented the disease profile of the patients in the region (six districts) which falls into the following categories: acute peptic ulcer, anemia, anti-natal, chronic obstructive pulmonary diseases, hyper tension, pelvic inflammation, renal calculi, upper respiratory tract infection and worm infection. This type of analysis has been possible because of computerized system of clinic management introduced right in the beginning. Also, the mobile clinic has been used in regions which are normally inaccessible and where organized medical facility is not available. This, I consider as the best form of reaching the healthcare to the neediest people in the country. This is a low cost solution with committed healthcare personnel and institutions. The clinical data provided by this model will be applicable for many hill zones in India and many other countries. The networked data provided by mobile healthcare clinics will be an important input for medical researchers, particularly the Pharma companies.

Now I would like to discuss about my experience with Pharma Research and Development laboratory and the production establishments.

I have visited number of Pharma industries in the country and also I have studied the research and development efforts from molecule to drugs. I found every Pharma industry has highly qualified researchers and they are busy and working hard to give to the country new cost effective drugs from molecule to drugs. Of-course it is going to take some time before we see good results. The major development efforts going on in our Pharma industries are in the area of anti-cancer drug and new anti-malaria drugs. In another industry, I saw anti-malaria vaccine development. Some of the Pharma industries are also working on medicine for cardiology, neurology and also anti-body products for cancer, which are in advanced stages of development. Also some industries are working on anti-diabetic therapies and new antibiotic development. Another important contribution to diagnostics is, manufacturing digital X-ray systems.

These experiences, give me the confidence that our Pharma industry is getting well equipped to produce Pharma products indigenously in a cost effective manner. We have to ensure the progress and ensure drugs are available in the country and abroad well in-time.

Now I would like to present the areas needing intensive research for cancer cure through nanotechnology.

Regenerative medicine: Advances in the development of nano-structured scaffolds and implants will pave way for new horizons in regenerative medicine. Development of smart drug delivery systems that can evade immunological response, target diseased parts and release the right dose of the drug can lead us closer to ideal therapeutic regimens. The drugs with such characteristics will be able to deal with effective treatment of cancer.
Strategies that can provide a breakthrough in cancer therapy are:

Targeted delivery systems: Development of targeted delivery systems that will deliver the drug only to the cancer cells is an important area of research. We have to get cost effective drugs through research. Simultaneously, the drug should avoid development of side-effects. The challenge is to identify a unique marker present or over expressed only in the cancer cells. Mostly folate receptors and epidermal growth factor receptors are popular choices as these are over-expressed manifold in cancer cells. In India, epidermal growth factor receptor antagonists (Immunotherapy/Vaccine) as Monoclonal Antibodies are produced by BIOCON. Hence a partnership between BIOCON and a nanotechnology system designer will facilitate development of cost effective delivery system to the cancer patients.
Convergence of bio-nano-info technologies can lead to the development of nano robots. Nano robots when they are injected into a patient, my expert friends say, it will diagnose and deliver the treatment exclusively in the affected area and then the nano-robot gets digested as it is a DNA based product.

High loading efficiency and stealth: Development of hyperbranched nanostructures such as dendrimers with high loading efficiency and stealth characteristics that will retard recognition by the immune system. This will enable longer circulation times for the delivery system and reduce frequent doses. The challenge here will be to strike a right balance between stealth characteristics, cellular uptake and right amount of drug release. Stealth characteristics can be incorporated by grafting polyethlylene glycol chains to the delivery systems. These are highly hydrophilic and have very fast chain dynamics and therefore retard adsorption of blood proteins. This is what has been done by Sun-Pharma. However, the cost of the drug is quite high. Further research and development are required to make the drug affordable by a common man.

Selective annihilation: Another important area is Inducing hyperthermia in cancer cells using carbon nano-tubes or magnetic nanoparticles that selectively annihilate only the cancer cells on exposure to infrared radiations or magnetic field respectively. The major issue to be addressed here is the specificity of targeting, elimination of the nanoparticles and use of a suitable external trigger to induce hyperthermia. Apart from these, many new targets for destruction of cancer cells are being evaluated using bioinformatics tools. The development of a cancer database coupled with various user-specified algorithms to predict specific interactions between the potential drug molecule and the receptors on the surface of the cancer cell not only aids in lead molecule development but also to elucidate the mechanism of cell kill and cyto-toxi-city. These researches will definitely lead to provision of cost effective nano-technology based medicines for cancer cure. R&D community in India and other partnering countries can work together on such intensive research programmes for other diseases specific to this region.

Spurious and Counterfeit medicines is an increasing concern for the patients, industry, and national policy-makers. It has become one of the key issues besieging the entire world - both the developing as well as the developed nations. The pharmaceutical sector is a strategic sector for India as it contributes to public health, generates positive effects on the Indian economy and improves the general level of welfare. It is crucial to bear in mind from the outset that the "pharmaceutical sector" in the broad sense includes a variety of other actors, ranging from suppliers of medicinal products ingredients (in particular the active pharmaceutical ingredient, "API"), importers, wholesalers (including parallel traders), retailers/pharmacies, and other traders (brokers, etc.). Concerning pharmaceuticals, reduced safety, quality, or efficacy can be life-threatening. In this respect, pharmaceuticals are distinct from many other consumer products.

Even one single case of spurious medicine is not acceptable because, in addition to putting patients at risk and undermining the public confidence in their medicines. The challenge is that wrongful duplication occurs in even low cost pharmaceutical products, many of which could be critical or life saving medicines. This makes it a very serious concern as such products not only harm the nation?s citizens but also potentially percolate across the national borders to the entire world. Such occurrence also results into a very wrong perception of the country it originates and immensely damages the reputation of a nation as the source and hub of spurious / counterfeiting activity.

The only way to combat such a serious menace is by adopting science and technology measures. There are several science and technology measures, which have been successfully developed which are really good as well as cost effective. These technologies can be easily integrated to provide a viable solution to the menace. Any packaged goods can use effective novel technology embedded packaging solutions which are difficult to copy yet cost effective and pose greater deterrence to the duplicator.

I have seen some company?s in India who have done remarkable research and development resulting in immensely viable innovations which can be used affordably by even low cost medicines. Such innovations include technologies in material sciences as well as electronics. These innovations can be the change agent to defeat social criminals who blatantly duplicate products wrongfully, causing great harm to people at large. I had been to one such innovative company called Bilcare in December 2007. They have done some remarkable work on several technology innovations in packaging materials and have also developed a unique Nonclonable security solution which can be effectively used to not only combat counterfeit by providing a means to identify the genuinity of the medicine but also provide capability to secure the supply chain which is the weakest link attacked by the duplicator to push in spurious medicines. I was extremely happy when I unveiled the technology and had asked the group of scientists to work further on the technology to make it totally adaptable to packaged drug products. I was informed that lot of additional research has gone into the application and adaptation processes.

There is, therefore a need for much closer interactions between the pharmaceutical manufacturers and the technology providers to instigate continual innovation process and enable the incorporation of outcomes of these innovations in the form of customized solutions which in turn will provide a greater level of security and confidence to the patients. I urge the pharmaceutical industry to support such innovations happening in our country and partner for looking into implementing such innovations which will result in great value to our citizens.

I have attempted to provide different strategies for providing cost effective medicare needed by citizens in different parts of the world. The strategies include:

a) Provision of comprehensive NFI including alternate systems of medicines for different diseases.

b) Open Source Drug Discovery (OSDD) programme.

c) International corporate social responsibility leading to cost reduction through sharing of knowledge.

d) Use of mobile medicare system for reaching the unreached in a cost effective way

e) Contribution of research and development by Pharma industry in partnership with educational institutions to develop cost effective products as a substitute for present treatment resume, particularly in the case of cancer.

f) The need for preventing spurious drugs entering into the market through innovative foolproof packaging.

The Pharma industries have also got to work on methods by which they can provide bulk drugs to large customers without high cost packaging for immediate use. This will be a very effective contribution of Pharma companies in providing cost effective healthcare. In addition, medical experts should also work on removing the perils of super-bug resulting out of indiscriminate use of antibiotics.

While we have certain generic drugs in India which are cost effective, the drugs particularly for cancer, TB, HIV/AIDS, and heart diseases are very costly, because most of them are under-license. It is essential for Indian Pharmaceutical companies to develop our own formulations which can be a cost effective substitute. In addition, Pharma companies have to ensure that there is a robust and reliable distribution system from warehouse to the primary health centre, so that there is seamless flow of right type of medicines to the patients.

With these words, I inaugurate the international conference on Equity and Access to Medicine. My best wishes to all the participants for success in all their missions.

May God Bless you.