India Fast Become Prime Location for Clinical Trials, but Vigilance Called for

India is fast becoming a prime location for clinical trials for many pharmaceutical giants, observers say.

Pfizer, BristolMyers Squibb, GlaxoSmithkline, Eli Lilly are among those big firms that conduct the trials in the country.

Currently over 226 clinical trials approved by the U.S. Food and Drug Administration (FDA) are in India.

Faced with the increasing costs of clinical trials and a shortage of willing participants at home, western drug companies are looking at off-shoring the trials to the third world.

India has perhaps the world's largest patient pool, it is pointed out. Moreover, it may be easy to pick out those who may not be taking any other medicine.

But the main consideration is costs — industry watchers say drug companies may save up to 50% of the costs of new drug development by conducting trials in India.

Big cities are favorite spots for these trials, with Delhi having 76 trials, Mumbai 86, Chennai 50 and Bangalore 64, it is reported.

Many clinical research organizations (CROs) have sprouted up, offering to carry out such trials. They are getting business worth up to 120 million US dollars a year. It is expected that clinical trials estimated to cost two billion dollars could end up in India by 2010.

The Center has made changes in laws and regulations to accommodate the clinical trial boom.

Apart from changes in patent laws, which will protect data confidentiality, initial or phase-1 trials are also permitted.

A Framework for Good Clinical Practices has also been announced. In the budget for 2007-08, the service tax on clinical trials was done away with.

However, many doubt whether India's top regulatory body, the Drug Controller General of India, is technically equipped to cope with the influx.

In recent years, there has been a spate of failures of clinical trials with many of the top pharma companies being forced to withdraw drugs after adverse reports. While Bristol-Myers Squibb terminated a new diabetes drug, Astra Zeneca halted work on a new drug for stroke patients. And Pfizer did so with its cholesterol-reducing Torcetrapib.

They all pull out only on realizing irreversible damage has been caused to the subjects. But no one will compensate them or their families.

Necessary measures to protect the health of the Indian citizens should be put in place first, urge activists. That is far more important than earning dollars, they stress.

Source-Medindia
SRM