India needs 50,000 clinical researchers by next year: Expert
Panaji | Sunday, Nov 22 2009 IST
 

India requires at least 50,000 clinical research professionals and 10,000 investigators trained in Good Clinical Practice (GCP) by the year 2012 when global clinical outsourcing investment in the Indian pharmaceutical industry is expected to touch a whopping US two billion dollar as against US 300 million dollar now.

''This calls for intensive education and training of human resources to meet the galloping demand of the clinical research industry in India,'' Ms Guljit Chaudhari, managing director, Bioinnovat Research Services, headquartered in Gurgon, Haryana, claimed.

Quoting Mc Kinsey study report on the subject, she told UNI here today that 30 per cent of the global clinical trials had been undertaken in developing countries and India is the most favoured destination for various reasons including higher efficiency factor and 50 to 60 per cent cost effective benefit over the US and European Union.

''With the availability of naive patient pool in India, the duration of clinical trials would be shortened thus paving way for quick launching of the new drugs into the market. This has put India on the map of sought after destinations for clinical trials which are expected to grow rapidly in the next 10 years,'' she said.

Quoting the authorities, Ms Chaudhari said the Drug Controller of India had approved conduct of about 100 clinical trials during the year 2005, 150 in 2006, 240 in 2007 and 450 in 2008. With parallel global clinical trials possible in India, the demand for trained manpower in clinical research had grown over the years, she said.

As of now, she said, the country had about 500 to 1000 investigators compared to 50,000 in the US. Of them, only 500 investigators had participated in GCP trials even as the government started encouraging development of the culture of global GCP quality trials in the country.

India, she said, had necessary infrastructure for implementation of GCP in accordance with the International Code of Harmonisation (ICH) with over 850 principal investigators (leading clinical physicians) who have conducted global trials in hospitals ensuring ethical compliance at investigator sites for patient safety.

The industry, she said, had rapidly grown with compounded annual growth rate of 110 per cent reaching more than 320 trials last year estimated to invest over Rs 1,200 crore, besides employing about 7,000 to 8,000 professionals as vouched by the clinical trial registry of the Indian Council of Medical Research(ICMR).

Interestingly, Bioinnovat, founded in 2005 as a Pharmaceutical Resource Organisation, had been engaged in providing leading certified post-graduate programmes in clinical research in partnership with the University of Pune and Goa University besides contract staffing solutions and regulatory services.

She was here in connection with the launching of PG Diploma courses in bio-statistics and clinical data magement and other professional courses in January next in collaboration with the Goa University which had the credit of launching a six-month PG Certificate course last year with tremendous success.

The courses, Ms Chaudhri said, were aimed at assisting research directors, investigators, monitors, auditors, statisticians and members of ethics committees in the appreciation and implementation of best practices in clinical trials involving medicinal productss, devices, nutraceutical and dietary supplements to meet regulatory requirements of the US, Europe, Japan and India which are leading drug developers in the world.

-- (UNI) -- 22BY5.xml

 

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