BioCentury
ARTICLE | Politics & Policy

Indian Supreme Court maintains hold on trials

October 25, 2013 1:10 AM UTC

India's Supreme Court said 157 clinical trials that it placed on hold in September need to be evaluated by two additional committees before the court will lift its hold, according to the Association of Biotechnology Led Enterprises (ABLE). After a rash of media reports and subsequent litigation related to clinical trial deaths, the Supreme Court in January directed India'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. Under the system, trials must be reviewed by a New Drug Advisory Committee (NDAC) and two other committees before the Drug Controller General of India (DCGI) can approve the trials to start. The Supreme Court said the 157 trials were approved prior to the new requirement and were thus only reviewed by an NDAC. The court did lift its hold on five trials that were approved under the new three-tier system. According to ABLE, the Indian government also said it will implement a requirement that trial sponsors obtain video recordings of patients providing informed consent. ...