Clinical trial ethics in India: One step forward, two steps back

The recent reporting of controversial drug trials being conducted by doctors of the government medical college and private practitioners on ‘mentally challenged’ patients in Indore has caused uproar.[5] It was alleged that for more than two years, from 2008 to 2010, trials were conducted flouting ethics guidelines. The Madhya Pradesh government levied a fine of Rs 5000 each on the doctors involved, and this was seen widely as being paltry and insufficient punishment.[6] As details emerged, questions were raised about the role of independent or commercial (as compared to institutional) ethics committees, improper documentation of consent, vulnerability of research participants as well as the thorny issue of private practice (and in this case, research in private clinics) by government doctors.