Clinical research has been a road unchartered and at times controversial, too, in the Indian context given the stringent bureaucratic hurdles that we are famous for, lack of a proper regulatory environment, lack of adequate number of trained people and competition from China and Eastern Europe among other things.
There was also this lack of knowledge and confidence among developed nations when it came to carrying out clinical research trials in India. Thus far, Indian pharmaceutical industry has only been known for its success in generic molecules and reverse engineering.
Many now believe that after generics, the next wave of growth for Indian Pharma would be in the drug discovery pipeline and development outsourcing. This is because efficiency of pharmaceutical research in advanced countries is under tremendous pressure owing to spiralling costs, falling productivity, growing costs of healthcare, etc.
It has provided India with a unique opportunity to propel from a past in reverse engineering to a more innovation-driven future in science and especially research.
The Government, too, has woken up to this fact and is putting in place a regulatory environment to carry out clinical research and drug discovery services.
Giving a boost
Union Ministry of Health, DCGI, ICMR and DBT are working in tandem to promote growth of clinical research. Competence in application of IT-enabled services and information technology and biotechnology as such has given a much needed thrust and boost to this segment.
Launching a new medicine involves a complex process that starts with identifying the gene that requires to be targeted, screening thousands of chemicals that could potentially work, researching their efficacy, testing them first on animals and, subsequently, on humans, and finally launching the drug.
Bio-equivalence and Bio-availability studies, a part of the whole drug discovery pipeline also play an important part in contributing to the growth of the industry in general and to mankind in particular as they help in reducing rising costs of new drugs.
Given the immense potential for employment this segment has for professionals from various disciplines the scope and growth for individuals per se seems to be unlimited with industry bigwigs predicting a business of around Rs. 10,000 crore in the very near future. The gamut of clinical research and drug discovery which comprises of bio-availability, bio-equivalence studies, clinical trial site management, clinical operations management, clinical trial management, multi-centric clinical trials, central bio-analytical lab facilities, data management, bio-statistics, report writing and global clinical trials - phase I, II, III, IV throws open the doors for students willing to pursue a career in clinical research like B. Pharmacy, M. Pharmacy, nursing, statisticians and medical doctors etc.
Careers
Fresh B. Pharm graduates can enter as Junior Research Associate (JRA) with pay around 6,000-8,000 per month, can be promoted within two years to Research Associate or Research Assistant with pay between Rs. 10,000-11,000 per month.
Fresh M. Pharm graduates can enter directly as Research Assistant or Research Associate with pay between 12,000 - 15,000 per month, can be promoted within two years to Senior Research Associate or Senior Research Assistant with pay Rs. 15,000 - 20,000 per month.
M. Pharm with PhDs can enter as clinical coordinators or protocol team leaders with clinical report preparation team leaders with between pay Rs. 25,000-30,000 per month.
Fresh M.B.B.S graduates can enter as physicians responsible for study activities and safety reporting and screening of volunteers with pay from Rs. 20,000-25,000 per month.
M.B.B.S graduates with fair amount of experience (minimum of five years and above in a hospital) especially in ICU and intensive care specialists can enter as Associate Clinical Investigators at Rs. 25,000 - 30,000 per month can be promoted within two years to Clinical Investigators with pay between Rs. 35-40,000 per month and within five to Senior Clinical Investigators, pay Rs. 45-60,000 per month.
M.B.B.S, M.D (Pharmacology) freshers can enter as Associate Principal Investigators -- pay Rs. 30-40,000 per month and can be promoted within two years to Principal Investigators, with pay ranging from Rs. 45-60,000 per month. Experienced MBBS/MD can enter as Head Clinical Unit with pay from Rs. 80,000-1lakh per month.
Fresh BSc/MSc (Statistics) can enter as statisticians with pay from Rs. 15-20,000 per month, which only increases with experience. There is scope for bio-medical engineering graduates too with pay Rs. 15-20,000 per month.
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