An “Apex Committee for Clinical Trials” has been constituted by the Union Health Ministry on the directive of the Supreme Court of India. Outsourcing Pharma.Com reports that this committee now requires developers of cancer treatments approved without trials to monitor the first 500 patients to assess the drug’s safety and efficacy. An analysis of the data acquired will need to be submitted to the Drugs Controller General of India, who will then forward it to the Technical and Apex Committees for scrutiny.
The new recommendation comes after the marketing approval was granted to Merck’s Zolinza (vorinostat), and Medivation and Astellas’ Xtandi (enzaltuamide), both treatments for cancer. Further, the Apex and the Technical Committees have approved 28 of 31 submissions for clinical trials.