News

Volume 9 Issue 1 - March 15, 2012

Government has no plans to stop drug trials on persons living with mental illness

D.N.I.S. News Network, India: In what can be termed as a gross violation of the basic tenet laid down by the United Nations Convention on Persons with Disabilities (C.R.P.D.), ratified by India, the Government has said that it does not have any plans to stop drug trials on persons living with mental illness. This was said by Ghulam Nabi Azad, Minister of Health and Family Welfare in the Rajya Sabha. He added that the Government considers such trials to be vital for establishing the safety and efficacy of a new drug and research in the area of drug discovery.

The Central Drugs Standard Control Organisation (C.D.S.C.O.) was asked to investigate the matter regarding drug trials on patients without their consent by the doctors of Mahatma Gandhi Medical College and Mental Hospital, Indore. Investigations revealed that the psychiatrists attached to the hospital had conducted 11 clinical trials during the period January 2008 to October 2010 at their private clinics.

As per Schedule-Y of the Drugs and Cosmetics Rules and Good Clinical Practice Guidelines recognised under the Schedule, persons living with mental illness, who are incapable of personally giving consent, are considered vulnerable subjects. However, the rules and guidelines do not prohibit clinical trials on persons living with mental illness. Informed consent from a legally acceptable representative of the patient is considered to be enough.