*1 Jan 2012* *BHOPAL* : Fending off criticism over the controversial drug trials on mentally challenged patients in Indore, the Madhya Pradesh government has now slapped a nominal Rs 5000 penalty on the 12 government doctors who were involved.
The penalty was for their failure to inform about the trials. The Madhya Pradesh Nursing Homes and Clinical Establishment (registration and License) Amendment Act 2003 requires doctors and hospitals conducting drug trials to inform state health authorities, Indore's Chief Medical and Health Officer (CMHO) Dr Sharad Pandit told The TOI. "We did not ask for names and other details of those on whom the trials were conducted, but the doctors should have furnished all details under the Act", Dr Pandit, who is also a state Joint Director of health department, said. This penalty move, however, has not convinced many about the government's intent in the issue. Health activist Dr Anand Rai, who had lodged a complaint in the issue, asserted that the Act provided for a maximum fine of Rs 50,000 for nursing homes and clinical establishments if they were not registered or did not furnish monthly data. "All drug trials were performed on patients who had gone to these government hospitals for routine treatment. It's a criminal offence to put them under drug trials without their consent", he said, adding that the fine imposed was the bare minimum, and was no deterrent. A government spokesman said instructions had been issued to ban new drug/clinical trials in the state's medical colleges and attached hospitals, from October 25, 2010. ``The state government is serious about the complaints in this connection. But we will now issue fresh guidelines after chalking out new parameters", he maintained. However, the doctors who had conducted the controversial drug trials have been claiming immunity from furnishing any details of any drug or vaccine trials, citing provisions of the Drugs and Cosmetics Act 1940 (rules of 1945) -a pre-independence relic. Incidentally, there is no provision in Schedule 'Y' of the rules giving powers to the states to monitor/regulate drug/clinical trials. But the government had asked the health commissioner and Chief medical and health officer, Indore to get medical establishments who had done Clinical Trials Registration with the central drug controller to get drug trial-related information from 38 doctors of the Public Health and Family Welfare Department. Subsequently, the chief medical and health oOfficer, Indore sought details form the president of the Nursing Homes Association and president of the Indian Medical Association, Indore. But government sources say they cannot do much more in the issue. "According to rules, the identity of patients put under clinical/drug trials should be kept secret. The doctors involved are now citing this provision. Under the circumstances, the State Government cannot do any direct investigation, which would involve identifying the patients", a senior health department official claimed. http://articles.timesofindia.indiatimes.com/2011-12-31/bhopal/30576129_1_drug-trials-government-doctors-clinical-establishment -- You received this message because you are subscribed to the Google Groups "Mental Health Advocacy (News 'N Views) India" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/MhaNewsViewsIndia?hl=en ------------- Affiliated Groups : MENTAL HEALTH ADVOCACY INDIA [email protected] Discussions on mental health law / policy / plan monitoring / human rights etc [email protected] India-specific news and views related to mental health [email protected] Information and support to carers of people with mental health issues [email protected] Mutual support and sharing of experiential knowledge, skills and social learning amongst peers
