Drug Trials, Ethical Violation and Feeble Regulations in India
Anand Rai, the doctor and the main whistleblower in Indore, and the Human Rights Law Network, a non-governmental organization in Delhi, plan to file public interest litigation this month with India's Supreme Court. Colin Gonsalves, founder of Human Rights Law Network said small penalties “actually reinforce allegations that it's a cover up.” He added “What India really needs is an investigation into the flow of money from the pharma companies to the CROs [clinical research outsourcing companies] to the doctors,” as reported by The Lancet. Rai was quoted saying “Doctors have deliberately violated all regulations and have reduced clinical trials to a money-spinning exercise.”
After another evaluation, a state government committee banned all new trials in Madhya Pradesh in October, 2010. The ban is still in place, though a state committee lately recommended lifting it. The state's health department then called for state as well as national approval of any trials; giving state health officials rights to audit and monitor records along with requiring doctors to report serious adverse effects within 24 hours.