Indian trial approvals up
India's Central Drugs Standard Control Organization (CDSCO) has approved 76 trials through May, on pace to top the 107 trials approved in all of 2013. The uptick in trial approvals comes on the heels of reforms enacted to tighten ethical guidelines for conducting trials. In January 2013, after a rash of media reports and subsequent litigation related to trial deaths, India's Supreme Court directed the country's Ministry of Health and Family Welfare (MHFW) to make reforms, including mandating a three-tier approval system to ensure clinical trials meet ethical requirements. At the time, MHFW also issued new regulations on the conduct of trials, including a requirement that trial sponsors provide compensation to patients who suffer injury or death during or as a result of the trial. ...