India CT regs would benefit China, IPN says

The Campaign for Fighting Diseases, part of the UK-based International Policy Network, a global development think-tank, has warned against the unintended consequences of a regulatory backlash against India's emerging clinical trial sector following the reported deaths of 49 infants at the All-India Institute of Medical Sciences in New Delhi (Marketletters passim). "The real winner will be the Chinese economy rather than Indian patients," the report's authors, Philip Stevens and Julian Harris, write.

The attractiveness of India as a clinical trial outsourcing destination is obvious, the IPN argues. A combination of a 60% estimated saving on the expense of running a study in India rather than the USA is compounded by the number of English-speaking physicians and scientists and faster processing times. However, regulations have already been tightened up in 2005, as part of a wide range of drug industry legislative reforms. The real problem, the IPN team warns, is lack of enforcement of existing rules. Any attempt to pile on further restrictions, given the bad publicity generated about the AIIMS case, could incite clinical trial firms to shift attention to China.