Regulation failing to keep up with India’s trials boom : The Lancet

Regulation failing to keep up with India’s trials boom

vía Regulation failing to keep up with India’s trials boom : The Lancet.

The Lancet, Volume 379, Issue 9814, Pages 397 – 398, 4 February 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.”

“Trials have become a lucrative business for clinical research outsourcing (CROs) companies—the third parties that do trials on behalf of drug makers. The CRO industry generated $485 million in revenue in 2010—11 and has been growing about 12% each year, according to consultancy Frost & Sullivan. The number of CROs grew from a handful before 2005 to more than 150 today. The top 20 CROs earn more than 70% of the industry’s revenues. However, there is no government registry for CROs in India.”

Esto que ocurre tan, tan lejos ¿tendrá algo que ver con América Latina?

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