Health ministry hiding facts in Indore clinical trial case?

Only one patients’ consent was not available, says health minister in Rajya Sabha

By Sonal Matharu
Published: Wednesday 14 March 2012

An inquiry conducted by the Union health ministry into the controversial clinical trials conducted in Indore on mentally challenged patients has found that the informed consent of only one of the 11 patients was not available. This was informed by health minister Ghulam Nabi Azad to the Rajya Sabha on March 13.

The clinical trials were for a drug for premature ejaculation.

The Central Drugs Standard Control Organization (CDSCO), a body under the health ministry, investigated the matter. It found that the doctors at Mahatma Gandhi Medical College and Mental Hospital (MGM) in Indore in Madhya Pradesh had conducted the trials on mentally-challenged patients between January 2008 and October 2010 at their private clinics and not at the government hospital.

“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,” said Azad.

Meanwhile, health activists in the state are unhappy with the Centre’s response. “The reply by the health ministry is incomplete. They are hiding facts. The doctors who conducted the clinical trials sought permission from independent ethics committee whereas they should have taken it from the ethics committee of the hospital they are associated with,” says Anand Rai, a public health activist based in Indore, who filed a complaint with the state health department on the issue.

He adds that Madhya Pradesh State Mental Health Authority also investigated into the matter but the health minister did not mention anything about their findings. “No one knows what happened to the investigation done by them.”

As per schedule-Y of the Drugs and Cosmetics Rules and good clinical practice guidelines under the schedule, mentally challenged and mentally differently able persons who are incapable of 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 such patients in clinical trials, informed consent is required from a legally acceptable representative of the patient. “The trials for this drug could have been done on healthy individuals also,” says Rai.

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