Drug Trials, Ethical Violation and Feeble Regulations in India

Bangalore: Drug trials continue to be a matter of concern for India. The ethical violations in clinical trials in the country have exposed the grey areas in the regulatory system, which has struggled to oversee the booming industry.

Five years ago medical trials were one of the most promising sectors of the country’s fast-growing pharmaceuticals industry. A wide range of reasons were considered favorable, like costs in India being 40 to 60 percent cheaper than trials in the U.S.; a large pool of patients from a diverse population; and high-quality hospitals with English-speaking doctors who could oversee trials. This in turn resulted in increase in the number of trials. In 2003, 40-50 clinical trials were seen in India. Contrastingly, 1852 trials were registered in 2011 on the government website Clinical Trial Registry India (CTRI). A massive 150,000 people were estimated to be taking part in clinical trials across the country.

However, the wave of the ethical violations at hospitals in Madhya Pradesh created controversy over clinical trials in India and tarnished a once-bright sector. Few experts say that the trials industry inflamed and outgrew controls for careful monitoring, training, and regulation.