I am indeed delighted to participate in the Inauguration of the Charter "Pharma Vision 2020", organized by 55th Indian Pharmaceutical Congress, Chennai. My Greetings to the organizers, participants, delegates and distinguished guests. The Indian pharmaceutical industry is one of the largest and the most advanced, well recognized industries in the developed countries. The pharmaceutical companies manufacture bulk drugs belonging to several therapeutical groups and has developed state-of-the-art infrastructure for production of all dosage forms. With this background, I was thinking what I could share with you today. I have chosen the topic "Challenges and Opportunities: Indian Pharma industry".

Present core competence of Pharma industry

Indian Pharmaceutical Industry worth $ US 4 billion retail sales in domestic market, in addition to US $ 2.6 billion in exports. Export growth is due to export of new molecules (Generic), especially to regulated markets. Through molecule exports we are only helping the developed countries for value addition. As reported in SCRIP WORLD PHARMACEUTICAL NEWS UK, India ranks 4th in the world accounting for 8% of world's drug production by volume and 1.5% by value. It ranks 17th in terms of export value of bulk actives and dosage forms. Indian exports are sent to more than 200 countries around the globe including highly regulated markets of US, Europe, Japan and Australia. The larger Pharma units number around 200 in addition to 8000 Small & Medium Enterprises (EMEs) during 2002-03, value of bulk drugs (Rs 65 billion) and dosage forms produced (Rs 242 billion) has grown by 15%.

With the excellent infrastructure and production setup, the prices of Indian medicines are also one of the lowest in the world. A number of buyers from developed markets from North America, Europe regularly source APIs (Associated Pharmaceutical Intermediate) and drug intermediates from India. Many Indian companies maintain highest standards in international 'SHE' requirements namely Safety, Health and Environmental Protection in production.

Due to the Government policy initiatives for strengthening research and development in Pharma sector by way of fiscal incentives and other steps to strengthen regulatory mechanism, new R&D set ups with excellent infrastructure are coming up in various regions of the country. Compared to the reported average R&D spending of 2% of turnover in the sector, a few leading Indian Pharma companies have increased their R&D spending to over 5% of their turnover, which is a noteworthy achievement. Results of the R&D, manufacturing of drugs with high quality cost effectiveness and availability world over and higher market penetration will make India to become the first in production from the present fourth place in the world.

Indian companies have also been making rapid strides in the field of Biotechnology. Recombinant DNA technology, in addition to the production of Hepatitis B Vaccines, is also being put into use for the manufacture of rDNA Insulin by two leading Indian companies. Companies have developed cost effective processes for Interferron besides working on newer vaccines and Diagnostic kits.

Pharma equipment industry in India is not only very well established and modernized but in comparison to similar equipment from a number of western countries, it is also cost competitive. We should provide thrust and aggressively market this product in the international market.

Healthcare Vision

In the Developed India Vision 2020, one of the important areas identified by experts is "Health Care", with the aim of promoting affordable and accessible health care. The expert team has identified three major diseases viz. tuberculosis, HIV and water-borne diseases and methods to combat these diseases.

The report has brought out multi-dimensions of health care problems in our country. The Vision of providing affordable and effective healthcare to our entire population goes much beyond the capability of any individual, institution or organisation. Technology is an important tool to give fast healthcare and we have to use it. This vision has to become multi-organisational missions leading to the generation of thousands of Goal oriented projects. These projects will have to be supported and nurtured not only by the Government, but also by our industry and philanthropic organisations. The most important ingredient of such a multi-organisational mission will be the leadership decentralized and yet linked together. For example, the academic institutions which do research on various technological systems, have to feed their knowledge to the industries, and should become tools for medical-care, which would not only produce cost effective medical products but also lead to adoption of nearby villages for medical care coupled with education.

The indigenous drug development in the form of vaccines, medicines and diagnostics will be very important to provide cost effective drug therapy to the one billion population. This will also help us in competing in the world market through export. Our products will have edge due to the product cost. Indian Pharma industries need to gear up to use this ample opportunity.

Research tasks

The interfacing between medical science and various other technologies has given rise to numerous techniques, both curative and investigative, and has provided the research workers numerous tools to pry into the working of various physiological functions right up to the molecular levels. Developments in bio-technology and molecular biology have now made it possible not only to design drugs for specific properties but also to deliver them to the specific sites where they are most required. Newer imaging techniques have now made it possible to obtain real time images of the various organs at a physiological and biological level and hence the right treatment is possible. Medical research will lead to identifying not only the genes that cause disease but also correcting the defects through gene therapy. Recent breakthroughs in stem cell research are likely to lead to the regeneration of diseased organs.

Molecule to drug

It is time that we develop a molecule to drug in the country. Human power for this is available in the country, but what we need to do is to organize ourselves to attain global standards which are essential if we have to develop a product that is internationally approved. This can be done by obtaining approvals from dynamic health councils and with partnership from pharmaceutical industries in India and abroad to develop the process of converting of a molecule to drug. As this now involves different technologies, pre-clinicals, phase-1 and phase-2 clinical trials, pharmacologists, bio-informatics etc. to work together, we need to develop skills of working together so that all the necessary questions in this regard are answered. Economics, time frame for development and risk of failures is high. A molecule can fail at the fag end of the process. These may be the major reasons for the lack of our country not being able to bring about this conversion. The regulatory authority for clinical trials and granting approvals for introduction of new drugs, needs to be made more efficient for speedy introduction of new molecules and drugs for human applications.

However, in the present scene of globalization, the West is looking forward to cut costs of production, without compromising on quality. India, with all its thrust on Biotechnology, stream lining of procedural methodologies in obtaining permissions etc., has to help in rapidity of such developments, rather than getting lost due to regulatory formalities. Although the governmental agencies reflect to such a mood, industries are yet not convinced of such an action, especially in Biotechnology. Governmental agencies thus should work together to achieve this, especially in the area of drug discovery to production. Our specific aim is to focus on anti-cancer, anti-diabetic and immuno-modulator compounds.

Information Technology

The need of properly harnessing all the powers of information technology is very important. IT has become very relevant to areas like pharmaceutical research because of the enormous amounts of data which has to be mined to arrive at some conclusions. By way of example, I would like to mention about the Human Genome Project on which a massive amount of data has started to be generated. The amount of data processing required is so huge and specialized that the new branch of 'bio-informatics' has started developing. As the volume of data generated grows, so does the demand for faster data processing technologies. Thus, to arrive at some destination in the area of 'bio-informatics', it is very necessary to deploy powerful information and communication technologies so as to be able to get a hold on gene sequences, expressions, protein structure delineation and population genetics etc. This all means that many Pharma education and research institutes should be keen to study and develop the area of Information Technology, particularly bio-informatics, and deploy it widely to make the best use of it in the pharmaceutical sector.

Tropical Diseases

It is generally felt that much work is not being done abroad on tropical diseases like malaria, typhoid and tuberculosis etc., because there is a feeling that multi-national drug companies do not hope to find high profit markets for their research products. India has to take the lead in these areas to remove the pain of poor masses of the tropics, which suffer from these diseases.

HIV/AIDS Vaccine

Apart from these tropical diseases another name is getting added very quickly and that is of HIV/AIDS. Efforts are being made all in the West to develop not only the retro-viral drugs for combating the disease but also to develop a vaccine for the prevention of HIV/AIDS. Here again, countries like India would have to fend for themselves because, I am told, that the AIDS virus, which is prevalent in our country, is of a different strain from that which affects the West and Africa. As such, our research institutes and professionals would require to develop their own drugs and vaccines to combat our strain of AIDS/HIV virus. As far as India is concerned, I understand that the anti vaccine for HIV/AIDS is in the advanced stage of development and getting ready for clinical trials. This programme needs highest priority from multi work-centres in a mission mode. Success in HIV/AIDS vaccine will indeed be a major milestone for the nation and also for other countries.

Conclusion

The pharmaceutical business in the WTO environment will have to be competitive. Competitiveness springs from the technological strength. The research and drug design, development and acceptance for introduction, is indeed a big mission. Particularly institutions of Pharmaceutical sciences need to understand the challenges - design to drug development and marketing. When you evolve Pharma vision 2020, you must identify all missions which will make drug production by India first in the world with a target of 20% in total value of the production in the world and global sales of drugs with the multinational companies established in the world. Here the most important component of success comes from creative leadership. In the present environment we need leaders whose leadership styles move from commander to coach, manager to mentor, from director to delegator and from one who demands respect to one who facilitates self respect. I am happy to see, the entrepreneur leaders of large and small Pharma industry, who will work for the above mission. I am happy to inaugurate the CHARTER FOR PHARMA VISION 2020.

I wish you all success. God bless you.

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