The union health ministry has given a clean chit to the controversial clinical trials involving mentally-challenged patients at Indore in Madhya Pradesh, following investigations at different levels that found the trials were done as per the norms.
βThe 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,β according to the official information on the issue.
The union health ministry had also asked the state government to conduct an inquiry into the alleged violations while the CDSCO, through its West Zone, also initiated investigations after the reports claimed that trials were done without consent of the patients.
The Supreme Court also had sent notices to the Ministry and the Medical Council of India (MCI) on a petition filed by NGO Swasthya Adhikar Manch seeking probe into the alleged drug trials without due permissions.
The illegal and inhuman practice was exposed in Indore during a sting operation carried out by a news channel some time back. The operation had showed as many as 233 mentally challenged patients were subjected to clinical trials in Indore without permission from their family members.
DCGI office also took views from three companies β Zydus Cadila, mCure and Intas β on the alleged deficiencies. According to earlier reports, around 233 patients in Indore were subjected to clinical trials to check the efficacy of drugs, including 42 patients for Dapoxetine, a drug used to cure premature ejaculation.