Drug discovery companies may be increasingly doing clinical trials in India and sending related work also across, but there is a large gap in the number of skilled people who conduct these trials, according to Mr S.R. Dugal, Chairman of ICRI which trains such professionals for the life sciences industry.
A large pool of these professionals are needed to monitor the drugs’ efficacy on patients and volunteers, compare similar drugs, collate data and also look out for side effects of drugs; they may work at hospitals, pharma companies or CROs (clinical research organisations) that do the outsourced work.
The domestic trials industry, which he reckons employs 50,000 people and is growing at a cumulative yearly rate of 50-60 per cent, will need 15,000 additional trained people in the next 2-3 years, well above a FICCI forecast of 12,000 people. A McKinsey report had predicted this size way back in 2003 when the wave was just rising, he said.
ICRI (Institute of Clinical Research, India), which Mr Dugal heads, says its six campuses bring out half the number of candidates who train at similar dedicated CR institutes after their formal education; and is expanding to new locations.
Interestingly, IT companies have become the largest hirers of clinical research professionals: their healthcare verticals have taken over the jobs in clinical data management, pharmacovigilance and medical writing, Mr Dugal told Business Line. “Today, IT companies such as TCS, Wipro, Infosys, Cognizant and Accenture in that order are the largest hirers of candidates graduating from CR institutes,” he said.
These are the very segments that are entering India in a big way. The data management industry, Mr Dugal said, has decided to shift en masse to India.
“Last year we had a batch of 600 M.Sc students, of whom 500 joined IT companies and only 50 went to clinical research,” he said. “TCS alone recruited over 100 (from ICRI) in the last one year; and until scam hit it, Satyam was a major player in this scene.”
According to Dr Arun Bhatt, President of the professionals’ body, the Indian Society for Clinical Research, “The issue here is not the number but how many of those qualifying are employable. Our experience is that only 10 per cent of these are able to clear industry’s screening process.” Nor does the industry need more institutions, said Dr Bhatt, who is President of Clininvent Research P Ltd, a Mumbai-based CRO conducts trials and related services.
“Assuming 15-20 sites per trial, around 7,000-9,000 investigators are participating in these trials. An experienced monitor or CRA (clinical research associate, normally a trained life-sciences graduate or post-graduate) usually monitors 5-6 sites. Considering this, India needs 1,500-2,000 CRAs a year.” Data management would need many more people.
Global CRO leaders such as Quintiles and more recently, Alvogen/ Norwich Clinical Services have scented the India trail. While CROs grapple with around 20 per cent attrition, Dr Bhatt said the industry also needed a large number of experienced professionals to do special tasks such as medical, regulatory, statistics, medical writing and project management.
“Many of them lack essential skills such as English language and communication to perform industry roles. Fresh entrants require a minimum of 3-6 months hands-on training before they can be put on the job.”
CR institutions, he said, need an accreditation system and should focus on the core knowledge areas such as regulatory issues, ethics, science, practical aspects of the jobs and communication skills. Dr Bhatt said the size of the purely clinical trials industry in the country was estimated at $360 million (around Rs 1,700 crore), which is still under two per cent of all global trials.
Mr Dugal said the total trials tally stood at 1,300, compared to 450 trials just three years back. If 453 trials were done in 2009, including 258 global ones, the regulator is said to have cleared 270 trials this year. Mr Dugal said by 2015, India could count on having 15 per cent of the world’s CR industry, more than a five-fold growth from the present.