Amar Jesani | Indian Journal of Medical Ethics | Vol 10 No 2 | 2013
In 2005, the government amended Schedule Y of the Drugs and Cosmetics Act, 1940, and Rules, 1945, to liberalise the conduct of global drug trials in India. Proponents of this policy had asserted that we needed less, and not more, regulation, in order to expand the business of drug trials. Many from the medical profession, the bioethics community and civil society groups have been critical of this policy. Instead of establishing a robust system of supervision and monitoring of drug trials to protect participants, the drug regulator, the Central Drugs Standards Control Organisation (CDSCO) of the Ministry of Health and Family Welfare (MoHFW), converted itself into a facilitator for industry. Its critics were called anti-science, anti-business and sometimes even anti-national.
Thus, it is no wonder that, since 2005, drug trials have been marred by numerous scandals and a public outcry about alleged violations of research ethics and participants’ human rights.