"No foreign Ph I trials for India," says Ministry

India's Economic Times reports that the Ministry of Health has overruled the Drug Technical Advisory Board, which had recommended allowing  foreign drugmakers to conduct Phase I clinical trials in the  country (Marketletter September 22, 2008).

Given that the tightly-contested, five-stage general election to India's  Lok Sabha (Lower House) was still underway as the Marketletter was  going to press and counting due to begin on May 16, the controversial  issue of Indian patients being seen to be "human guinea pigs" is one  that politicians would prefer to avoid, at least for now.

Outsourcing pharmaceutical studies is considered a major growth  opportunity for India, with a report by audit firm KPMG last year  suggesting that the market could expand by up to three times its 2007  level, from $200.0 million to $500.0 million-$600.0 million. Drug firms  can save an estimated 60% in India compared with the European Union  or the USA, KPMG said.