|Year : 2011 | Volume
| Issue : 5 | Page : 489-491
Clinical pharmacology: Prospects and development in India
Nilima Kshirsagar1, Vijay Kumar2
1 National Chair (Clinical Pharmacology), Indian Council of Medical Research, Dean, ESI-PGIMSR MGM Hospital, Govt. of India, Parel, Mumbai, India
2 Scientist 'F' & Head, Basic Medical Sciences, Indian Council of Medical Research, New Delhi, India
|Date of Web Publication||15-Sep-2011|
National Chair (Clinical Pharmacology), Indian Council of Medical Research, Dean, ESI-PGIMSR MGM Hospital, Govt. of India, Parel, Mumbai
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Kshirsagar N, Kumar V. Clinical pharmacology: Prospects and development in India. Indian J Pharmacol 2011;43:489-91
Subsequent to the appointment of one of us (NAK) as Chair of Clinical Pharmacology of Indian Council of Medical research (ICMR), it was decided to prepare a plan for the development of Clinical Pharmacology in India. This is an exciting opportunity for all of us involved in this discipline. While preparing roadmap, some of the ideas and thoughts that have emerged in consultation with colleagues from India and abroad have been put down here.
| » Historical Development and Current Status|| |
Clinical Pharmacology is a relatively young discipline. The term was coined by Harry Gold in 1950s. It involves scientific study of drugs in man, their rational use which includes personalized medicine, safety and efficacy of medicines, consideration to cost, availability, etc. In recent years, the scope of Clinical Pharmacology has expanded to contribute more proactively to public health, to development of drugs from bench to bedside to marketing and life thereafter.
The discipline was started in India in 1960s. Since then, it has been contributing to development of new drugs, clinical research, clinical trials for new drug, new drug regimens, rational use of drugs, pharmacogenetics, etc. Contributions in these areas have come from various institutions like Council for Scientific and Industrial Research (CSIR), ICMR, the centers of excellence developed by ICMR, World Health Organization (WHO), departments in academic institutions, Pharmaceutical Industry, etc.  However, these developments have been rather slow and inadequate to meet the future challenges.
Indian Pharmaceutical Industry has made rapid strides since 1970, largely due to revised patent laws, which permitted manufacturing and marketing of patented novel chemical entities by alternative, non-infringing processes. Now, with the formation of World Trade Organization (WTO) in 1995 and obligation of member countries to comply with TRIPS provision (the Agreement on "Trade-Related Aspects of Intellectual Property Rights"), it is imperative for them to initiate drug discovery programs in house. While some companies have invested and started these, the efforts are inadequate. Basic biology work is done in universities, government organizations/institutions like National Institute of Virology, Centre for Cellular and Molecular Biology, National Institute of Immunology, National Institute of Research in Reproductive Health, etc. However, with few exceptions, it is inadequate to lead to product development. Further, most of these organizations are not mandated to develop a drug/product or vaccine. Academic institutions including pharmacy colleges and Indian Institutes of Technology have been active in using technology for the development of drugs and devices. However, again a vast majority of their work remains to be translated into a product that can be of use.
The Pharmaceutical Industry, looking for profit, develops drugs for areas with large profit margin - drugs for the rich. Indian pharmaceutical companies have focused on cancer, diabetes, obesity and dyslipidemia. While there are agencies like WHO, Medicines for Malaria Venture, Drugs for Neglected Diseases Initiative, Bill and Melinda Gates foundation and Clinton Foundation which are providing support to drug development for HIV, TB, malaria, Kala Azar and other neglected diseases, there is paucity of work in developing drugs and drug delivery systems which are suitable for the rural areas. Here, the drugs need to be such that they can be safely delivered by health workers or self-administered. In rural areas, there is also shortage of medicines. Government has several initiatives such as Janaushadhi Yojana to improve the distribution system. However, there is still a gap between need of medicines and availability. There is also gap between availability of information on rational use of drugs to health workers and patients. A study in Bihar showed the lack of knowledge and its improvement amongst patients and health workers after viewing an educational DVD on Kala Azar and use of miltefosine.  WHO and Government of India have pressed upon rational use of drugs. However, there are only a few hospitals which have drug and therapeutics committees, hospital infection control committees or standard treatment guidelines. Additionally, personalized medicine, especially using genetic data, has advanced in western countries. There is mushrooming of tests, many of which have not been validated. There is a possibility that soon these will become available in this country leading to their irrational use.
| » Future Challenges, Changes, Opportunities and Needs|| |
Against this current scenario, there are a large number of future changes and challenges, both on the national as well as the global scenes. Dr. C. T. Dollery, a world renowned expert and one of the pioneers in Clinical Pharmacology from UK, has reviewed Clinical Pharmacology growth and the possible measures to consolidate the existing skill base and future expansion. He has suggested the development of experimental and translational medicine, contributing to personalized medicine, service support to pharmacotherapy, teaching medical students and practicing doctors.  Price Water Cooper (PWC) 2020 vision estimates world pharmaceutical market to be $ 1.3 trillion and Indian Pharmaceutical Industry to be $ 20 million by 2020. But India will be competing with other emerging markets like China and Brazil. While traditional pharmaceutical institutes do everything from R and D to commercialization themselves, PWC predicts that to prosper in future, they will need to improve their R and D productivity, reduce costs, tap potential and emerging economies, switch from selling medicines to managing outcomes. They cannot achieve these on their own and will have to collaborate with academic institutions, hospitals, technology providers and various other service providers (nutrition, physiotherapy, exercise, etc.).  The Pharmaceutical Industry will need to go beyond medicine and laboratory. Pharmaceutical and healthcare value chains will get intertwined. They will need access to outcome data, multidisciplinary skills and will have to work with technology.
Pharmaceutical companies are foraying in rural areas with network of sales force, considering the 20 million middle class people living there. However, the life expectancy in rural areas is 12 years less than that of urban areas and hospital bed per 1000 is 0.2 in rural against 1.1 in urban.  Challenges of providing healthcare to rural population include thin population, lack of communication, poor education, scant information, lack of qualified doctors and other healthcare providers, insufficient infrastructure and storage facilities. But now with the Government initiative, the infrastructure is developing, there is rise in income level and thrust on rural healthcare program.
How can ICMR, other departments of Government of India and the discipline of Clinical Pharmacology contribute to lead in these changing circumstances and scenario?
| » Future Development of Clinical Pharmacology in India|| |
In view of the great need and the opportunity, ICMR with its large number of research institutions, subcenters and centers of excellence, Department of Science and Technology (DST), Department of Biotechnology (DBT), CSIR, Ayush, Pharmaceutical Industry and Medical Council of India (M.C.I.) should join hands for development of Clinical Pharmacology in India. The time has come to start an Institution of Clinical Pharmacology, Pharmaceutical and Translational Medicine, develop centers of excellence, and provide fellowships for training young aspirants.
| » Clinical Pharmacology, Public Health and Drugs for Rural Areas|| |
There should be development of Clinical Pharmacology, Pharmaceutical, and Translational Medicine Institute and it should link to public health to develop expertise, information, services, training in bringing out safe and effective economic products that will help in healthcare of population in India and other countries, particularly in rural and remote areas, especially to improve the health indices. Development of drugs, drug delivery systems, combinations, dosage regimens, devices, vaccines and techniques which are suitable for diseases, environment, healthcare delivery system and infrastructure prevalent in rural and remote areas needs to be promoted.
There is a surge in the country in the development of new technologies (e.g. information technology and nanotechnology). The Government of India has declared 2011-2020 as the decade of innovation to find new solutions in many areas to achieve our goals of inclusive and sustainable growth - in healthcare, energy, urban infrastructure, water management and transportation. We cannot continue with business as usual. Solutions available from developed countries are also not applicable all the time. They are often too costly and at times not sustainable.  It would thus be apt that a technology consortium is formed. Already developed technologies can be proactively selected and further new technologies should be promoted to develop new products to meet the healthcare needs of rural India. Clinical research and translational medicine units need to be set up that will carry out early phase, proof of concept studies and further translational studies through a network (consortium) of medical colleges, hospitals, specialized patient databases and disease-specific patients.
| » Training|| |
The dearth of trained manpower in the country is repeatedly emphasized. National guidelines for training programs for Clinical Pharmacology, Clinical Research, and Pharmacovigilance need to be developed. This will help in guiding and improving the current scenario of uncontrolled growth of clinical research training organizations in the country.
Training Program for PhDs
There are a large number of students who are keen on doing PhD in Clinical Pharmacology. There are very few opportunities in the country. The eligibility criteria vary between different universities. The skills to be acquired and the registration need to be standardized. There should be national guidelines as well as training opportunities.
Training Pharmacy Students
The pharmacy education has undergone a major change. The Pharm D, a 5-year program, envisages training in Clinical Pharmacology in years 3 and 4. This provides enormous opportunity to develop training modules and provide training and assistance in developing the standards of education. These trained Pharm D students manning hospitals and other healthcare service providers can be a key to promoting the rational use of medicines.
| » Reaching Out to Patients/Consumers/Society|| |
Rational use of drugs is crucial for safety and effectiveness of drugs. It is important for prolonging the useful life of drugs and avoiding development of resistance. There is need to carry out research and development of communication methods and educational material for rational use of drugs for doctors, health workers and community. This can be done in collaboration with mass media communication experts, field studies and by development of material in specifically identified (thrust) areas.
| » Outcome Research|| |
There is considerable emphasis in private sector as well as public sector on computerization. In private sector, most of the emphasis is on billing. In public sector, several central and state government organizations have invested in developing computerization programs. However, due to the large patient load and shortage of manpower, the implementation of computerization of hospital records is still being done only at a few hospitals. Systems for carrying out outcome research, to collect data on patient treatment outcome for response, antibiotic drug resistance and adverse drug reactions should be used at different healthcare settings to develop standard treatment guidelines and to design further studies in this direction.
There is need to develop new tests, carry out studies on marketed tests for validation and to develop/harmonize protocols for developing and testing pharmacogenetic and other personalized medicine tests. There are a number of laboratories in the country which are currently working on pharmacogenetics in areas such as resistant epilepsy, schizophrenia, hepatotoxicity, etc. It would be useful to bring the groups together for studies on phenotyping and evaluation/validation of the marketed tests.
| » Pharmacogenetics|| |
| » Pharmacovigilance|| |
There is need for developing a robust pharmacovigilance system in the country. The Government of India has now approved a pharmacovigilance program for spontaneous reporting from tertiary care hospitals/medical colleges. Involvement of private practitioners, and secondary and primary level centers in collaboration with Indian Medical Association (IMA) and public health department would bridge the gap further. There is future need for risk evaluation management for new drugs, for which Drug Controller General (India) [(DCG(I)] should develop the appropriate systems. Needless to say that training with an accredited program is the need of the hour.
| » Alternative System of Medicine|| |
Ayush, CSIR and ICMR, in collaboration with various other organizations, are conducting extensive research on various aspects of standardization, development and testing of drugs from alternative systems of medicine (ASMs). It is being repeatedly emphasized that in India, while there are over 6 lakh doctors of modern medicine, there are an equal or greater number of doctors trained in alternative systems who are prescribing drugs of modern medicine without receiving any training for it. There is need to review the situation and consider the development of training modules for doctors from ASM, especially those practicing in rural areas, which would help in their safer and rational use of select drugs.
| » Way Forward|| |
Stalwarts like Dr. U. K. Sheth, Dr. Ranjeet Roychaudhary, Dr. Ashok Vaidya and Dr. P. L. Sharma have initiated the discipline of Clinical Pharmacology in the country. There are now many young students who are keenly interested in the drug development process. Secretary, Department of Health Science Research, Government of India, and Director General, ICMR, have taken the initiative to give a real boost (and funds) to the discipline in the centenary year of ICMR. However, the government industry, academia and health services must collaborate. The proposal for development of Clinical Pharmacology in India has been presented to the ICMR Scientific Advisory Committee on Basic Sciences. In this connection, an ICMR-sponsored brainstorming session with participation of experts from Pharmaceutical Industry, physicians, pediatricians and public health experts was also conducted recently in Mumbai in December 2010, the proceedings and recommendations of which have been submitted to ICMR. The experts emphasized that 11 th National Five Year Plan (2007-2012) has envisaged essential medicines list, standard treatment guidelines, safe drugs, their rational use and dissemination of information to achieve target health indices, such as reduction in infant mortality rate (to 30/1000 live births), maternal mortality ratio (to 100/100,000 live births) and malaria mortality by 60% by the year 2012.  A major boost is required for development of Clinical Pharmacology and other overlapping disciplines of translational and pharmaceutical medicines, as much of the laboratory work is not getting translated to benefit the patients. A need was felt to network, collaborate and work together to translate technology into product development. Changes and updating of regulatory requirements for new types of products were also highlighted. The experts recommended for early phase proof of concept studies, pharmacovigilance, pharmacogenetics and outcome research.
We hope and expect that ICMR/Department of Health Research (DHR), DST, DBT, CSIR/Department of Scientific Industrial Research (DSIR) and AYUSH will join hands to formulate the appropriate policy and provide funds for a concerted action.
| » Acknowledgments|| |
Dr. V.M. Katoch, Secretary, Department of Health Science Research, Government of India, and Director General, ICMR, is gratefully acknowledged for providing the initiative and encouragement for preparing the proposal. Dr. S. D. Seth, Dr. Ashok Vaidya, Dr. Ranjeet Roychaudhary gave helpful suggestions in preparing the proposal and Dr. Robin Ferner (UK) and Dr. David Lehman (USA) provided the constructive comments which is gratefully acknowledged.
| » References|| |
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|3.||Dollery CT. Clinical pharmacology - The first 75 years and a view of the future. Br J Clin Pharmacol 2006;61:650-65. |
|4.||Price Waterhouse Cooper LLP. Available from: http://www.pwc.com. [Last cited on 2011 Jun 29]. |
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|7.||Report of the Working Group on Population Stabilization for The Eleventh Five Year Plan (2007-2012). Planning Commission, Government of India, New Delhi. Chapter 3: Strategies to achieve population stabilization, p. 12. |
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|[Pubmed] | [DOI]|