India's economic growth is experiencing an upswing with the growth rates touching 8 per cent. It has largely been accomplished due to growth in agriculture, industry and services. Clinical research in India is one of the emerging service industries for global drug development. The opportunities and potential are immense in this sector both for the contract organizations and pharmaceutical industry engaged in drug discovery. With IPR round the corner many initiatives have been taken by the government and the industry to nurture clinical research. One such initiative that has helped was to develop "Clinical Research - Road Map for India" at a conference held by CII in 2003.

India's emerging clinical research industry is experiencing some positive strokes ushering in changes that will make it a preferential destination for carrying out clinical research.

The established paradigm of India's economic advantage, core capabilities and expediency wasn't a big driver for industry to derive its expected growth. The lacunas that had blunted its growth were regulatory framework for the approval of clinical trials, functioning of the ERBs, GCP training and compliance, adequate patent protection, issues of patient being exploited as " guinea pigs".

However, the continuous efforts on the part of industry and the government have led to spin off changes that will bring in a great deal of confidence in India and its capabilities to do quality research.

On the regulatory front the Schedule Y, now very close to final approval and legislation has brought positive changes that will help the pharmaceutical industry and research being done by them. Clinical studies in India can now be conducted at par with the development Phase outside India for NDA. Another most important milestone that has been achieved is the permission granted by DCGI to permit the phase I trial for NCEs discovered outside India. Regarding timelines the DCGI talking at CII meeting has himself assured that the adequate resources will be in place to handle large number of CT applications pending with the authority.

Ethical Review Boards and their functioning have been suspect and prime area of concern. ERBs have now started functioning based on their written SOP's with a realization that ERB functioning is an area of scrutiny for regulatory inspections. In order to facilitate ERBs to regulate their functioning, ICMR has issued " Guidelines for preparing standard operating procedures (SOP) for Institutional Ethics Committee for Human Research". A large number of ERBs have prepared their SOPs based on these guidelines. Nonetheless, another feather in the cap.

A spurt in clinical trial activities has proportionally increased GCP training as sponsors are covering newer sites and imparting them the required GCP training. Efforts are going on to incorporate GCP guidelines in PG curriculum in medical as well as paramedical courses.

With India, being a signatory to TRIPS, and post 2005 patent protection guaranteed, has infused a sense of security among many international players who were holding back their research on new molecules in India. With IPR implemented the product and the data security issues will not hound the clinical trial opportunities India will have in future.

Clinical trial subject's right and safety is a highly sensitive spot and a fear of Indian population used as guinea pig is slowly going away from the minds of policy makers and general population. However, it is now advocated to conduct some high-end research in India for diseases like multidrug resistance tuberculosis, cancer, diabetes and HIV to enable Indian population to get an access to new treatments.

Improvement in healthcare system that supports clinical trial has also shown positive changes in the recent past. All major hospital labs and private labs are seeking accreditations like NABL and CAP. The source documentation has improved; the retrieval and archival processes have also smoothened in the recent past. The functioning of hospitals especially corporate ones is based on SOP's.

The future is indeed bright. The potential of India is not merely confined to " cheap labor" but a hub for skilled workforce with domain expertise. The strength is not merely economics and high patient number but consistent high quality research while maintaining timelines thereby shortening "time to market", therapeutic expertise and technological support.

- The authors are with Eli Lilly and Company (India) in the capacities of Sr. CRA and Medical Director respectively