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LATEST NEWS UPDATES | Drug trials: Panel for stringent action, docs fined Rs 5,000 each by Milind Ghatwai

Drug trials: Panel for stringent action, docs fined Rs 5,000 each by Milind Ghatwai

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published Published on Jan 2, 2012   modified Modified on Jan 2, 2012

Twelve government doctors involved in alleged illegal clinical trials in Indore have been slapped a fine of Rs 5,000 each when a probe committee had recommended stringent action like prosecution and cancellation of licences.

The paltry fine has invoked strong reactions from health activists who called the action an eyewash and demanded that the government immediately suspend the doctors if it was serious about penalising them and setting an example.

The 12 doctors attached to M Y Hospital, Indore, and 66 other government and private doctors were involved in the trials conducted on children and mentally challenged patients among others in alleged violation of rules by not taking consent of the subjects and also by not informing the health authorities.

However, the fine has been imposed under the Madhya Pradesh Nursing Home and Clinical Establishment Act (Registration and License) Act of 1973 (amended in 2003) for not maintaining records of tests and treatment and not providing details to the Chief Medical and Health Officer.

CMHO Dr Sharad Pandit, who had set up the two-member probe committee, told The Indian Express that the report had been submitted in June and he sent reminders leading to the action.

The 12 government doctors run their own private clinics and none of them was registered. Pandit said they had first claimed that they did not conduct any trials but the team confronted them with details available on a Central government website.

The committee also found that most of the 78 guilty doctors had taken permission from institutional ethics committees in a way to avoid scrutiny. In some cases, committees based in Jaipur and Ahmedabad gave permission for trials in Indore.

Besides initiation of criminal proceedings and cancellation of practising licences, the committee had also recommended departmental action against government doctors but the government simply chose to look the other way even though the matter was raised in the Assembly.

Another government probe had found that many patients had died when they were being subjected to the clinical trials.

All the 78 doctors refused to provide information about the trials citing the provisions of the Drug and Cosmetic Rules, 1945, which insist on maintaining secrecy about patients. The same rules don’t permit states to regulate or monitor clinical trials.

Dr Anand Rai, the whistle-blower in the matter, said doctors had made crores and would not mind paying the paltry fine. Even the maximum possible penalty of Rs 50,000 had not been imposed, he added.

Amulya Nidhi of Swasthya Adhikar Manch said the government was misleading people by claiming to have cracked the whip on a report submitted months ago. “The doctors should be suspended to facilitate a proper probe,” he said.

Leader of Opposition Ajay Singh alleged the government was sparing the guilty by imposing a nominal fine. He called for a CBI inquiry into the drug trials because they involved multinationals.

The state government had banned drug/clinical trials in government medical colleges and hospitals attached with them with effect from October 25, 2010. The ban is still in force.

The Indian Express, 2 January, 2012, http://www.indianexpress.com/news/Drug-trials--Panel-for-stringent-action--docs-fined-Rs-5-000-each/894681/


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