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04 January 2012

Madhya Pradesh govt. takes action on docs conducting drug trials on kids & mentally challenged persons

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By Pervez Bari

Bhopal: A fine of Rs. 5,000 each has been imposed on 12 doctors of autonomous medical colleges and hospitals attached with them in Madhya Pradesh for conducting drug trial on children and mentally challenged persons.

After review of all the cases, instructions have been issued for banning new drug/clinical trials with effect from October 25, 2010 in medical colleges of the state and hospitals attached to them. The State Government is serious on the complaints received in this connection and fresh guidelines will be issued after chalking out new parameters, an official press release said.
Though there is no provision in Schedule 'Y' of the Drug and Cosmetic Rules 1945 for powers to states to monitor/regulate drug/clinical trials, yet instructions were issued to Madhya Pradesh Health Commissioner and Chief Medical and Health Officer, Indore to get registered under Registration of Clinical Trial Registration of Central Drug Controller and then seek drug trial-related information from 38 doctors of Public Health and Family Welfare Department. The doctors had expressed inability to provide details of drug/vaccine trial citing provisions of Drug and Cosmetic Rules 1945.

Chief Medical and Health Officer, Indore also sought details in this connection from President of Nursing Home Association and President Indian Medical Association, Indore. Though drug trial is regulated by Drug and Cosmetics Rules 1945, yet fine to the tune of Rs. 5,000 each has been imposed on 12 doctors for not maintaining records of tests and treatment and failure to provide requisite details to Chief Medical and Health Officer under Madhya Pradesh Nursing Home and Clinical Establishment (Registration and License) Act.

As per legal provisions, identity of the patients undergoing clinical/drug trial should be kept secret. The doctors are citing this very provision. Under such circumstances, the state government cannot do direct investigation with these patients.

Meanwhile, in what may seem like a horrendous nightmare, more than 200 mentally ill patients in Indore were subjected to drug trials to check the efficacy of various drugs. The report of the Economic Offences Wing, (EOW), claims how consent was not taken from patients and how more than 80 patients underwent severe after-effects of the trial.

Of the 223 patients, 42 were tried to check the efficacy of Dapoxetine, a drug used to cure premature ejaculation, media reports said. The trials were conducted by doctors of the mental hospital attached to the Mahatma Gandhi Medical College, Indore, between 2008 and 2010. The use of Dapoxetine in premature ejaculation is still under review by US FDA, as it needed more clinical study. Only a few European countries have approved its use.

The issue was also raised in the Madhya Pradesh State Legislative Assembly in July, but the state Chief Minister Shivraj Singh Chouhan's reply in the House was incomplete. The government's detailed reply came during the assembly's winter session that concluded on December 3 last.

Meanwhile, concerned over the irregularities in the clinical trials conducted in Indore by the various private and government doctors, the US Food and Drug Administration (US FDA) has now intervened in the matter. In an e-mail correspondence with whistleblower Dr. Anand Rai, the deputy country director of US FDA India Officer Albinus D'Sa has asked for the details of the American companies whose trials were conducted without following the required protocol. Like, Drug Control General of India, the US FDA in USA is the authority that gives permission for conducting trials.

[Pervez Bari is a senior Journalist based at Bhopal, Madhya Pradesh. He is associated with IndianMuslimObserver.com as Bureau Chief (Madhya Pradesh). He can be contacted at pervezbari@eth.net]

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