The Hindu Business Line : Domestic clinical trials market booms

India is turning out to be one of the hottest destinations for conducting global clinical research, owing to a huge patient pool, easy recruitment of patients, and high cost savings.

Thomas K. Thomas

New Delhi, July 25 The clinical trials market is booming. The number of clinical trials being conducted in India has doubled from 170 in 2006 to 350 at the end of 2008, according to the Central Drug Standard Control Organisation.

And going by the indications in the first six months of 2009, the number of registered clinical trials in the country is likely to touch a new high.

Already between January and June this year, 130 trials have been registered with the drug regulator. Since the drug regulator has made it mandatory for clinical research organisations to register all drug trials from June onwards, a significant jump in the actual numbers is expected this year.

India is turning out to be one of the hottest destinations for conducting global clinical research, owing to a huge patient pool representing both chronic and infectious diseases, easy recruitment of patients, and high cost savings.

Although India now occupies a very small pie of the global opportunity, analysts predict that nearly 5 per cent of the global clinical trials will be done in India by 2012.

Ramping up

The drug regulator is also ramping up its system and infrastructure to bring more transparency and ethics into clinical trials.

Apart from making it compulsory for all Clinical Research Organisations to register themselves and the trials being undertaken on behalf of any pharmaceutical company, a system is also being set up to track the volunteers who participate in these trials.

The regulator is putting in place a finger printing technology for the volunteers, which will make sure that the same persons are not involved in two different trials at the same time. The technology will connect all the CROs to prepare a database of volunteers.

The regulator has also issued guidelines making it mandatory for the CROs to keep written records of trial-related duties and functions being carried out.

They will also have to keep a record of quality assurance and control, according to the standard operative procedures designed for the purpose.