Visakhapatnam: When asked if any action had been taken against Dr N. Nookaraju, superintendent of the Government Hospital for Mental Care in Vizag, for alleged irregularities in clinical drug trials since the report was out two years ago, Director of Medical Education Dr G. Santha Rao said, “The inquiry committee report regarding clinical trials in the Government Hospital for Mental Care has been received by the Directorate of Medical Education. Various departments like vigilance have requested information in connection to this report. The procedure is going on.”
The inquiry committee consisted of three doctors from AMC — chairman Dr N. Dwarkanadh, professor of surgery and two members, Dr A. Krishna-murthy, professor of medicine and Dr Himakar, professor of psychiatry.
The committee had found that Dr Nookaraju had conducted many trials at the hospital by entering into a tripartite agreement with contract research organisations, signing on behalf of the hospital superintendent without informing him. In just three years, 2008-2011, 417 patients were subjected to clinical drug trials.
When contacted, Dr Nookaraju said, “All the required permissions were obtained for the trials and the money given by contract research organisations was spent on the requirements of patients and trial procedures. The clinical trials were conducted without flouting norms. The trial was an agreement between me and the research organisations and all permissions were acquired from authorities like DME, AMC and the ethics committee.”
“I was the principal investigator. They are not illegal, and are conducted in many government hospitals including, King George Hospital,” Dr Nookaraju added.
Drug Control Admini-stration, deputy director of Eluru division T. Ravi Kumar, who is also the in-charge of Vizag, said, “Drug trials on mentally ill patients must be avoided as they might give consent without considering its negative effects. Moreover, we as a state body do not have enforcement power in drug trial cases as it comes under the Centre.”
