The number of deaths in India resulting from clinical trials has increased to an unendurable figure of 2,868 during the period 2005-20121

Pharmaleaders Newsdesk

There is huge potential for the clinical research industry in India, which offers attractive opportunities for contract research organisations. The clinical trials industry in India was estimated at $485 million in 2010 by Frost & Sullivan and is anticipated to grow at 17 per cent CAGR from 2009-15, remaining the largest clinical trial market in Asia after Japan. The growth is accelerated not only by the global majors but also the domestic companies that have seen a rapid growth over the past three years.
India has a varied genetic pool and a significant number of Indians suffer from acute chronic diseases. This can be win-win situation: for patients who don’t get or can’t afford good treatment and pharma companies who need patients to conduct clinical trials to develop new medicines. The cost of a phase I trial is estimated to be 50 per cent cheaper in India, while that of phase II is 60 per cent less in terms of direct cost and estimated time savings. The vast healthcare system makes it easier for international clinical research organisations to conduct studies in the country.
Moreover, India has about 600,000 doctors, 45,000 hospitals and around 900,000 beds in both private and public hospitals, with most having electronic medical record facilities. All this makes it easier for international clinical research organisations to conduct studies in the country. The Indian clinical research industry grew to about Rs 8,000 crore in 2010-2011. According to ASSOCHAM, it is expected to employ 50,000 professionals in the next five years. Indian companies are expected to conduct over 15 per cent of global trials, which can increase the employment opportunities for life science and medical graduates four-fold. But the industry faces a few challenges for these targets to be met. There have been inadequacies in the clinical trials publication practices wherein trials with only positive results are published while the failures or ineffectiveness of drugs are not publicised.
“Clinical Trials” and debates associated with it have been in headlines since past few months pursuant to the strict view taken by the apex court on the matter. The number of deaths in India resulting from clinical trials has increased to an unendurable figure of 2,868 during the period 2005-20121. If on the one hand this figure relating to number of deaths resulting from clinical trials is fearful, on the other hand the decline in the number of clinical trials and approval given for conducting such trials in last few months is equally shocking. Till April 2013, only 12 (twelve) clinical trials have been approved by the authority as compared to almost a three digit figure in last year2. This certainly raises a concern for the future of clinical trials in India- country which once was perceived as a fertile place for growth of clinical trials by most of the multi-national corporations. Currently estimated at USD 500 million, India’s clinical research market was projected to more than double.