On December 1, new guidelines for the conduct of global clinical trials took effect in India, aimed at simplifying and bringing the country’s regulations into line with international standards.
The changes, which have been announced by the Drug Controller General of India, state that clinical trials will now be classified into Category A and Category B. Category A will include trials whose protocols are already approved by recognised and developed countries such as Australia, Canada, Germany, Japan, South Africa, Switzerland, the UK and USA, and also by the European Medicines Evaluation Agency. The aim is to reduce the approval time for these trials to around four weeks, from as much as six months previously.
All applications which are not classified Category A will be listed under category B, and their approval is expected to continue to take between eight and 12 weeks.
Discussing these moves earlier this month, Drug Controller General M Venkateswarlu said: “By weeding out the delays, we hope to make the country a preferred destination in the outsourcing segment,” India’s Financial Express reported.
Costs of clinical trials in India are around one-tenth of the levels in the USA, and it is forecast that the business could be worth around $300 million to India by 2010, according to a recent report from KPMG. By Lynne Taylor