A day after HRD Minister announced the formation of a expert panel to probe into the controversy over clinical trials, King George Hospital (KGH) Superintendent G. Arjuna on Tuesday rubbished the allegations of carrying out the procedures on patients without the prior consent of their families as required under the Ethics Committee rules.
“The traials were conducted on patients only for standardisation of proven drugs. One must not confuse between drug trials and clinical trials,” Mr. Arjuna told The Hindu.
Referring to the controversy, he said they had received the mandatory clearance from the Ethics Committee of the KGH and Andhra Medical College (AMC) and the Drug Controller General of India (DCGI) and the State Drug Control Administration for conducting the tests on 100 patients with prior consent.
Multi-centre trial
“This was a part of a multi-centre trial. As the number of centres was reduced from six to two and KGH is well acclaimed for paediatric care, we were told to carry out the trials additionally on 206 patients. This was done with prior approval from the Ethics Committee and the DCGI,” Dr. Arjuna pointed out
The committee had also written a letter to the DCGI, seeking approval for adding more patients under the study. However, the letter was somehow misplaced due to technical problems,” he added .
Meanwhile, Mr. Arjuna said, a new Ethics Committee was formed and was aware of the development. “This led to the reports appeared in a section of the media that the trials were carried out in violation of law. In fact, on knowing about the trials conducted on 306 patients, the new panel had sought clarification from the head of the paediatrics department,” he added.
‘Death not due
to clinical trials’
The death of Rama Rao, 45, from Vizianagaram was not due to clinical trials, he claimed stating that he had visited KGH long ago with complaints of diabetes and hypertension. The autopsy report had cited bronchopneumonia.