Even as India is fast becoming a hub of global clinical trial industry, the lack of adequate trained investigators and trial sites to conduct human studies will pose a major threat to the growth of the segment, if not addressed immediately, say experts.

The country, which participates in 3.2 per cent of the global phase II studies and seven per cent of the phase III studies, currently has only around 1000 trained investigators and 750 clinical trial sites. There are around 700 active clinical studies being conducted in India at present and the number is expected to grow at 20 per cent per annum in next few years.

A good investigator, with all his experience, can only conduct two to three trials at a time though the growing contract research industry demands more investigations to be done by the same investigator in prominent cities at present, says Dr Arun Bhatt, president, Clininvent Research Pvt Ltd.

"Even though we can find out more specialised physicians from the Indian hospitals, there is a lack of training for them to conduct delicate clinical trials at present. We find it difficult to get senior physicians to train on conducting clinical trials. Since the number of trials in India is expected to shoot up, there is an urgent need of academia to act with the support of the industry to bring in more trained investigators," comments Dr Bhatt.

"This is one major issue that could be a bottleneck to the growth of the clinical trials industry, if not addressed promptly," says Dr Anand Bidarkar, vice president, business development, Siro Clinpharm Pvt Ltd. However, he added that the number of physicians trained on Good Clinical Practice (GCP) has been increased from 500 in the year 2006 to 2500 at present in India.

"The real issue is that the investigator-project ratio in super speciality centres in leading cities is not healthy, as these doctors are compelled to take up more number of projects when compared to some doctors in other parts of the country are doing a single project at a time," comments Dr Bidarkar.

The country, which was handling two to three percent of the global human studies, has grown to handle almost five per cent of the total studies in 2009. Given that these figures do not include the post marketing clinical studies conducted in the country, and with the growth expected in near future, the country needs more number of trained investigators in various specialty areas in prominent cities.

Even though companies like Siro Clinpharm has already initiated centre of excellence to train the specialised doctors in GCP, the process of training more investigators has to be intensified by the academia and the industry to meet the challenge, he added.

According to a study in 2008, the clinical trial participation in India has recorded a growth rate of 20 per cent in the period between 2002 and 2006 even as the participation of US, Canada, UK, Mexico and France has been shown negative growth ranging from -4 per cent to -12 per cent. However, the trial density, the number of recruiting sites divided by country population in millions, in India is one while US and Canada has a trial density of 120 and 98 respectively.