Regulation failing to keep up with India’s trials boom

Amy Yee | The Lancet | Vol 379, No 9814 | 2012

Ethical violations in clinical trials in India have exposed gaping holes in the country’s regulatory system, which has struggled to oversee the booming industry. Amy Yee reports from New Delhi.

Just 5 years ago, clinical trials in India were seen as one of the most promising sectors of the country’s fast-growing pharmaceuticals industry. Analysts touted several favourable conditions: costs that were 40–60% cheaper than trials in the USA; a large pool of patients from a diverse population; and high-quality hospitals with English-speaking doctors who could oversee trials. As a result, the number of trials in India rapidly increased. In 2003, there were 40–50 clinical trials in India. In contrast, 1852 trials were registered on the government website Clinical Trial Registry India (CTRI) as of June, 2011. Across the country there are an estimated 150 000 people participating in clinical trials.

However, a spate of alleged ethical violations at hospitals in the poor, landlocked state of Madhya Pradesh have created controversy over clinical trials in India and tarnished a once-bright sector. Some experts say that the trials industry overheated and outgrew controls for careful monitoring, training, and regulation.

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