Clinical trials of drugs on mentally challenged patients

NEW DELHI (PIB) --- The Central Drugs Standard Control Organization (CDSCO) has   investigated the matter regarding drug trials on patients without their consent by the doctors of Mahatma Gandhi Medical College and Mental Hospital (MGM), Indore. Investigations revealed that the psychiatrists attached to the MGM hospital had conducted 11 clinical trials during the period Jan, 2008 to Oct, 2010 at their private clinics.  In one case only, the investigator did not have the original Informed Consent Forms at the site as the same were stated to be in the possession of the sponsor company.

As per Schedule-Y of the Drugs and Cosmetics Rules and Good Clinical Practice Guidelines recognized under the Schedule, mentally challenged and mentally differently able persons, who are incapable of personally giving consent, are considered vulnerable subjects.  However, there is no prohibition under the said rules and guidelines that clinical trials cannot be conducted on such patients. For enrolling of such patients in clinical trials, informed consent is required to be obtained from a legally acceptable representative of the patient.

The Government has no proposal to stop drug trials on patients as it considers such trials are vital for establishing safety and efficacy of a new drug and research in the area of drug discovery leading to newer, safer and more efficacious drugs.

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