Drug trials : Madhya Pradesh chief secretary fails to report to NHRC

 Feb1, 2012, Asish Gaur TOI

INDORE : The National Human Rights Commission (NHRC)’s order to the Madhya Pradesh chief secretary to report to it the details of the controversial human drug trials in Indore, has run into a procedural wall.

Taking suo motu cognisance of a TOI report on drug trials conducted on 233 patients of the government-run mental hospital attached to the Mahatma Gandhi Medical College in Indore, the NHRC had asked the chief secretary to furnish the details by last Tuesday. But the latter has not obliged, maintaining that the laws allow the concerned doctors to keep all details of the trials confidential.

Forty two of these patients were given Dapoxetine, a drug to cure premature ejaculation. However, an earlier report of the Drug Controller General of India (DCGI) had said they were not mentally ill, but were seeking psychiatric help for premature ejaculation.

Among other points. the NHRC had also specifically asked the MP chief secretary to report if the doctors had followed Indian Council of Medical Research (ICMR) guidelines, while conducting the trials on the basis of approval obtained from independent ethics committees attached to private hospitals _ bypassing the medical college’s own institutional ethics committee.

The chief secretary, Avni Vaishya, told TOI that he was not in a position to submit the report.”The doctors have kept the trial documents under wraps. The details are confidential according to the laws for the conduct of clinical trials. Only central regulatory bodies such as the DCGI or MCI can investigate the matter,” he said.

The NHRC, however, has decided to press the issue. NHRC spokesperson Jaimini Kumar Srivastava said the commission will write to the chief secretary again. “We have not received any communication from the chief secretary as of now. The time allowed to submit report has lapsed. We are going to write again asking to submit the report at the earliest.”

2-FEB-2012

NEW DELHI : Union health minister Ghulam Nabi Azad on Wednesday asked an explanation from the Madhya Pradesh government on the malpractices surrounding the recent clinical trials conducted in Indore.

“Irregularities were found in the clinical trials conducted there and the state government needs to explain what action has been taken against the doctors involved,” he said.

The drug controller general of India (DCGI) had recently issued a stern show cause notice to five doctors of Indore’s Mahatma Gandhi Medical College for not following good clinical trials (GCT) norms, while conducting clinical trials on 241 patients visiting the College’s psychiatry ward.

Notices had also been sent to three companies – Cadilla, Mcure and Intas – to explain the deficiencies at the earliest.

The DCGI has threatened blacklisting of the doctors from all other trials they are involved in if they fail to reply at the earliest. Two hundred and forty one patients in Indore were subjected to clinical trials to check the efficacy of various drugs, including 42 for Dapoxetine, a drug used to cure premature ejaculation.

An independent team of investigators sent by the DCGI submitted its report to the health ministry recently.

The report has cleared the investigators of carrying out the trial on “mentally ill” patients. The investigating team however took serious cognizance to the fact that investigators did not posses with them the original informed consent forms.

The forms were taken away by the sponsors of the trial, “which is a serious offence”.

A ministry official said, “Most of the patients were suffering from erectile dysfunctions and were being treated by psychiatrists from that medical college. That is why they were visiting the psychiatric ward and not because they were suffering from any mental illness.”

“However, show cause notices have been served on the doctors for the serious administrative lapses and deviation from GCT guidelines while carrying out the trial,” the official added.

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• Brinda writes to DCGI on Indore clinical trials (thehindu.com)
• NHRC plans draft legislation on rights of patients (kractivist.wordpress.com)