In the modern day era clinical trials are the cornerstone of drug discoveries as only studies on human volunteers can prove the safety and efficacy of a new drug or procedure.

The key to the success of any clinical trial is the availability of the human volunteers to participate in the study and the availability of skilled Investigators who would conduct the study on them in an ethical way adhering to the Good Clinical Practices (GCPs).

Traditionally the new drug development and clinical research has been the forte of western countries and particularly the US. In US the pressure of patient recruitment and retention is the main cause of delay or failure of studies. It is predicted that within the next two years, 30% of the global clinical trials will take place outside the United States and western Europe and India would emerge as favourable destinations.

Clinical research potential in India
.Population:1 billion plus
.Medical Colleges: More than 250 which includes premier Institutes of National Importance
.Private Sector : About 500 major corporate hospitals and about 12000 smaller private hospitals
.Public Sector: About 600 district level hospitals, about 3000 community health centres, 23000 primary health centres
.About 500000 qualified physicians
.Growing number of GCP trained medical community to skilled to match global standards.
.English Speaking skilled medical professionals
.Excellent IT skills and facilities for data management
.Wide variety of genetic and socio-cultural pool of population
.Wide spectrum of communicable and non communicable diseases, with low per capita drug expenditure
.Roughly 30 million diabetics and an equal number of heart disease patient

India calling
With Product Patent regime, appropriate regulatory laws and GCPs in place India is becoming a global destination of clinical trails. The name earned by India and the way the country has become the global IT and ITES hub, bodes well to become the next major clinical trials destination too. Besides the IT skills India offers excellent hospital facilities, good number of skilled medical professionals and most importantly a large pool of patients/ volunteers for the successful conduct of clinical trials. Companies are attracted to India not only because of the huge patient pool and skilled workers, but also because many potential study volunteers are "treatment naïve," meaning they have not been exposed to the wide array of biomedical drugs that most Western patients have, says Stefan Ecks, lecturer in social anthropology at the School of Social and Political Studies in Edinburgh.

Cost advantage: There is a huge cost advantage while conducting the Trials in India. Understandably the Human resources and also the payment to volunteers is a fraction of what it would cost in the west. It is estimated that this reduction could be an overall 40-60% of the costs compared to the Developed World (2004 Study by Rabo India Finance)

Estimated growth: Predictably there is huge potential for growth over the next 4-5 years in India. The compound annual growth rates (2002 to 2010) of Indian clinical trials is expected range from 30-50 per cent.

CenterWatch has predicted that by 2010, the industry will spend around US$ 250 - $300 million on clinical trials in India. McKinsey estimates much higher figure of US$ 1-1.5 billion by 2010. But Ashish Singh, vice president of Bain & Co., a consulting firm that reports on the health-care industry is even more optimistic as according to him by 2010, total spending on outsourcing clinical trials to India could top $2 billion. Same enthusiastic predictions are made by consultancy major Ernst & Young, who say the total market for clinical research activities in India is expected to touch $1.5-2 billion by 2010.

Regulatory environment
The Drug Controller General of India is the regulatory authority in the country. The Schedule Y to the Drugs and Cosmetics Act is the law of the land and lays down the regulatory requirement for conducting clinical trials in India. While the Indian GCPs are similar to the ICH GCPs followed in the west but at a few places appear to be even more stringent than the western ICH GCPs. A thorough knowledge of Indian GCPs would be necessary while undertaking the trials in India

Emerging potential
The number of clinical trials conducted in the country is still very small about 175 last year. The number of GCP trained professionals is about 500 at present. Compare thiswith the figures in US where annually about 60000 trials are conducted and there about 40000 GCP trained professionals.

Currently the trials are being conducted in about 25-30 reputed hospitals in major metros in the country. Again this needs to be increased many fold and can be done with imparting GCP training to investigators and ethics committee members and upgrading infrastructure at many other public/ private hospitals in and outside the metros. Also there is an urgent need for campaigners who will build the public awareness about clinical research.

There are roughly 50-60 CROs operating in the country about half of this number is based in the Southern city of Bangalore alone. Pharma majors such as Dr Reddys, Ranbaxy, Biocon, GSK have established their CR division in India. Also companies like Reliance, Infosys, TCS, Accenture have entered the field. Major Hospital Groups have taken up multiple trials for. Eg, the Apollo Hospitals Group handled about 75 trials in the last year.

The GCP training to professional has been mostly in house or through short workshops. Only recently about 5-6 reputed training Institutes such as Institute of Clinical Research, India have come up offering exclusive courses on clinical research and imparting GCP training to the students and professionals.

In summary, there is a tremendous opportunity available today for global entrepreneurs to invest in almost every aspect of growing clinical trials industry in India. It is just the beginning of the boom that is going to last and will bring lasting benefits to the health infrastructure of the country and to the people everywhere.

(The author is clinical trial consultant, Garden City College and Clinical Research Foundation, Bangalore )