India could allow Ph I/0 tests for foreign firms

India's Central Drugs Standard Control Organization is looking to increase the number of early-stage clinical trials in the country with a proposal to allow foreign drugmakers to conduct Phase 0 or Phase I clinical studies. At present, only Indian firms are licensed to carry out such testing, with foreign pharmaceutical companies restricted to Phases II and III.

Due to a combination of low costs and a large number of English speakers with relevant skills, India has become a leading center for international clinical trials. A report by audit firm KPMG examining the prospects of the country for drug studies suggests that the market could expand by up to three times its 2007 level, from $200.0 million to $500.0 million-$600.0 million. By outsourcing studies to India, pharmaceutical firms can save an estimated 60% compared with the European Union or the USA.

Surinder Singh, the Drug Comptroller General of India, noted that the CDSCO has taken a number of initiatives to boost the attractiveness of India for foreign research-based pharmaceutical firms. These include revisions to the Patent Act, measures to protect trademarks (Marketletter September 8) and the creation of an R&D fund.