Trials in mentally challenged patients from Indore, MP, India have received a clean chit from the union health ministry to the debatable clinical trials after different levels of investigations ascertained that trials were performed as per the prescribed norms.
Official information on the issue outlined that, “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.”
The State Government was compelled to conduct an inquiry into the alleged violations at the behest of the union health ministry; meanwhile, the CDSCO commenced investigations following claims by a report that trials were performed without the consent of the patients.
A recent sting operation executed by a news channel exposed the illegal and inhuman practice in Indore wherein approximately 233 mentally challenged patients were subjected to clinical trials without consent from their family members.
Three companies – Zydus Cadila, mCure, and Intas were consulted by the DCGI office for their views on the alleged deficiencies. Earlier reports revealed that the 233 mentally challenged patients were exposed to clinical trials to determine the efficacy of drugs, including Dapoxetine (tested on 42 patients), a drug used for the treatment and cure of premature ejaculation.