Address at the Convocation of National Institute of Pharmaceutical Education and Research (NIPER)

CHALLENGES TO PHARMACHEUTICAL INDUSTRIES

I am delighted to participate in the second convocation of the National Institute of Pharmaceutical Education and Research (NIPER). I would like to congratulate the Director, the faculty members and staff for shaping the young minds into Pharmaceutical specialists and leaders. Today the students of the third and fourth batches of the masters and doctoral programmes are passing out and will join the pharmaceutical industries which serve this industry in various capacities both in India as well as abroad.

Vision for Medicare

A report on "Health Care in India" has been prepared by a panel of leading doctors and medical technologists in the country. It reports the typical problems facing us for two decades in the health care and possible solutions. The expert team has identified three major diseases viz. tuberculosis, HIV and water-borne diseases, by next decade as methods to combat the diseases. The other diseases are cardiovascular diseases, neuro-psychiatric disorders, renal diseases and hypertension, gastrointestinal disorders, eye disorders, genetic diseases, accidents and trauma, which need our attention. We should see how the advancement in technology could be put to use to improve the health care system of the country. Such an effort will make cost effective medical technology and devices available and accessible to all the citizens of our country. This will contribute for nation's progress as a strong body and sound minds are essential to accomplish anything.

The report has brought out multidimensions 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 a 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 decentralised and yet linked together. For example the academic institutions which do research on various technological systems, will be tools for medical-care have to be fed to their knowledge to the industries which not only productionise cost effective medical products but also adopt nearby villages for medical care coupled with education. NIPER has to have partnership with R&D labs and industries for developing indigenous medical care equipments, devices and consumables.

The interfacing between medical science and various other technologies has given rise to numerous techniques both curative and investigative and has provided the research worker with 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 identify not only the genes that cause disease but also correct the defects through gene therapy. Recent breakthroughs in stem cell research are likely to lead to the regeneration of diseased organs.

The role of genes in heart diseases and stroke is now universally accepted. The apo-B gene is responsible for the cholesterol management in the body. My friend, Dr. B. Soma Raju informs me that as a clinician he is looking toward two major approaches for gene therapy for heart diseases: treating the heart muscle itself and treating veins and arteries. Molecular biology will also have a clear impact on the science and practice of psychiatry in near future.

Molecule to drug

It is time that we develop a molecule to drug in the country. Humanpower 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 are 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 to work together preclinicals, Phase 1 and phase2 clinical trials, pharmacologists, Bioinformatics etc we need to develop skills of working together such that all the necessary questions in this regard is 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 able to bring about this conversion.

However, in the present scene, globalization, and the west looking forward to cut costs of production and without compromising on quality. India with all its thrust in Biotechnology, streaming 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 anticancer, antidiabetic and immunomodulator compounds.

Intellectual Property Rights

We are now fast moving into the world of Intellectual Property Rights and Patents under the new international regimes which are unfolding before us. To make sure that we do not lose out to any of the IPR issues, it will be necessary to properly document all our research work and to put in our claims for patents whenever we feel it worthwhile to do so. NIPER should become the repository of IPR related activities not only to ensure that we protect our Intellectual Property of the modern times, but also to ensure that our repository of traditional medicinal knowledge is properly documented and can be put to strategic use to prevent IPR piracy.

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 organizations like NIPER 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.

MBA Programme

I am very happy to see that NIPER is keeping abreast of the developments which are taking place in the market and to this effect, they have introduced an MBA programme in Pharmaceutical Management with effect from 2003. It is heartening to note that this programme has been developed by deployment of in-house academic and professional expertise and is indicative of the forward looking and market-oriented approach of NIPER. Here, I would also like to add that pharmaceuticals is one industry in which we need to have a very strong research-industry linkage. For this, one must believe in 'industry-oriented' and 'industry-driven' research. We need not be overtly worried about basic research and research for the sake of research. After all, to be alive in the educational market, our Universities and institutes have to develop a strong industry-research orientation which will not only provide them a linkage with the market, but will also give an element of financial independence and autonomy to organizations like NIPER.

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 the institutions like NIPER has to understand the challenges - design to drug development and marketing. Here the most important component of success comes from creative leadership. In the present environment we need leaders whose leadership styles which move from commander to coach, manager to mentor, from director to delegator and from one who demands respect to one who facilitates self respect.

Wish you all the best.