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Premature drug trial sparks controversy in India

By Julie Mabley | Posted in Wednesday December 21, 2011 0 Comments | bookmark this page Share | bookmark this page RSS
mentally ill patients in drug trials

Clinical trials of Dapoxentine, a premature ejaculation treatment drug, were conducted on 233 mentally ill patients in India by government doctors, reports the Times of India.

Government doctors of a mental hospital attached to the Mahatma Gandhi Medical College in Indore, Madhya Pradesh, did the trials at private clinics between January 2008 and October 2010 to check the effectiveness of Dapoxentine in treating ejaculation problems, the daily newspaper notes.

After the heated discussion on the issue in the state’s assembly, Shiraj Singh Chauhan, the chief minister of Madhya Pradesh, disclosed the names of five doctors involved in the trials - Dr Ramgulam Rajdan, Dr VS Pal, Dr Ujwal Sardesai, Dr Abhay Paliwal and Dr Pali Rastogi, tells the Indian English-language daily.

Answering the question raised in the assembly, he told that doctors took prior permission from independent ethics committees of private hospitals for conducting the trails. The Indian broadsheet learns that all the clinics where the trials were conducted are not registered with district chief medical and health office.

Commenting on the status of registration of the private clinics used for trails, Dr Sharad Pandit, chief medical and health officer told the Times of India that dean of MG Medical College recommended them to register few of the clinics, adding that now that government is giving non-practicing allowance to some doctors, his office won’t be registering them.

Denying the crime, Dr VS Pal and Dr Abhay Paliwal, two of the doctors involved in the trails, said that approval from independent ethics committees was enough for conducting trails in private clinics and seeking permission from institutional ethics committee of Mahatma Gandhi Medical College was unnecessary.

Citing the guidelines issued by the Indian Council for Medical Research (ICMR), the Times of India discloses that independent ethics committees can only approve trails for only those researchers who work in institutes that do not have their own institutional ethics committees.

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