Boom time for clinical researchers
The fast-track pharmaceutical and healthcare industries could morph India into a hub of clinical research — poised to become the fastest growing sector in the life sciences
Even as the BPO (business process outsourcing) industry is utilising contemporary information commun-ication technologies to transform India into ‘the back office of the world’, the fast-track pharmaceutical and healthcare industries could also morph India into a hub of clinical research which is poised to become the fastest growing sector in the life sciences.
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| Gupta: huge personnel shortage |
"There is an immediate requirement in the Indian pharmaceutical industry of 10,000 people in the area of clinical research. India apart, internationally too, there is a dearth of trained manpower in this sector. According to a McKinsey & Co report, the global clinical trials outsourcing opportunity in India is estimated at an annual billing of $2 billion (Rs.9,000 crore) by the year 2010 when the demand for clinical research professionals will rise to 50,000," predicts the eminent Dr. S.K.Gupta, dean of the Institute of Clinical Research (India) and former head of pharmacology at the All India Institute of Medical Sciences, Delhi.
Unsurprisingly, pharmaceutical companies are scrambling to sign on trained professionals whose pay packages are getting bulkier. Trained pharmacists and clinicians are required for various genres of clinical research starting from site monitoring, site management, clinical data management, data analysis, report writing, to report submission, presentation and publication. Given the sensitivity of the process, clinical trial professionals need special academic qualifications. Graduates/ postgraduates in zoology, biology, microbiology, biotechnology, botany, molecular biology, biochemistry, genetics, pharmacy, statistics, information technology and management are eligible to enter the field of clinical research.
A career as a trained clinical professional is worthy of consideration because remuneration packages are weighty. According to a US-based personnel recruitment and head-hunting agency (Center Watch) normative annual pay for a senior clinical research associate in 2001 was $72,000 (Rs.34.2 lakh); project manager, $74,000; medical writers, $58,000; business development managers, $90,000 and clinical research coordinators, $40,000.
"Globally there has been a paradigm shift in the pharmaceutical industry and nearly two-thirds of R&D expenditure is allocated for drug development. Of this clinical research accounts for 70 percent of the time and resources spent in drug development. The discovery of new drugs requires investments of millions of dollars with the cost of developing a new drug steadily increasing from around $200 million (Rs. 900 crore) in the early nineties to over $800 million in the new millennium," explains Gupta.
Gupta has impeccable academic and experiential credentials to comment upon the unfolding scenario in the pharma-ceutical industry, and clinical research in particular. A Ph D in clinical pharmacology, DSC, FIACS, he retired as head of the pharmacology department of AIIMS in 2004. He is also president of the Indian Pharmacology Society and an emeritus professor at ICMR (Indian Council of Medical Research). Having published over 300 papers in national and international science journals, he is the recipient of the distinguished services award in medicine and surgery of the International Academy of Cardiovascular Sciences, and has also authored several pharmacology textbooks.
According to Gupta, a large and growing number of western multinational drug companies have identified India as an ideal society for clinical research. Firstly India has numerous government funded medical and pharmaceutical institutions with state-of-the-art facilities. Secondly India has a large, well-trained English-speaking professionally qualified work force. Moreover the cost of conducting clinical trials is 50-70 percent lower than in the United States or European Union.
"An additional factor behind India emerging as a favoured destination for clinical research is that alternative systems of medicines like ayurveda, unani, siddha, homeopathy are practised with equal fervour. Thus, clinical studies for their evaluation can also be easily conducted. These are the reasons why India is attracting global collaborative contract proposals for conducting clinical trials with many front-line pharma companies setting up clinical research organisations here," explains Gupta. Among the several clinical research organisations which have sprouted recently are: DiagnoSearch; Specialty Ranbaxy Ltd; Quintiles Clinigene; Eli Lilly; Reliance Clinical Research Services; Lotus Lab — all of whom are on a recruitment spree.
Gupta is of the opinion that critical research is still in its infancy here and there’s need for more capacity and capabilities in terms of education, regulatory infra-structure and creation of a pool of specialised research investigators. To this end, in 2003 Gupta promoted the Institute of Clinical Research, India (ICRI) in Dehra Dun. The institute awards a two-year Master’s degree in clinical research, regulatory affairs and related areas. An autonomous institution ICRI is affiliated to the Dr. MGR Deemed University in Chennai, which is approved by the ministry of HRD, government of India and University Grants Commission. ICRI established a centre in Mumbai last December which offers a one-year postgraduate diploma programme in clinical research and trials management, open to MBBS, BAMS, BHMS, BDS, B.Pharma, Nursing, B.Sc (life sciences), clinical research and pharma professionals.
"In ICRI we combine the practical and theoretical aspects of formal education with internships of six months during the last semester of the two-year course. We need many more such training institutes. There is a huge gap between the requirement of trained personnel and the number of skilled people available," says Gupta.
Little wonder their pay packets are becoming bulkier!
Indra Gidwani