Kerala Government to Curb Unethical Practices in Clinical Trials
In the wake of reports of several clinical trial centres in the state violating the principles of human research ethics, the State Government has decided to formulate a Clinical Trial Registry under the Drugs Control Department.
The State Drugs Controller has been entrusted with the task of formulating guidelines for the Clinical Trial Registry.
When contacted, Drugs Controller P Hariprasad said that he had received the government order in this regard.
‘’The officials have been asked to prepare the guidelines on the basis of the government’s direction. We hope that the guidelines will be prepared in two months’ time,’’ he said.
Sources said that the registry would include details of the title of study, hospitals and clinicians involved, type of research and in-patient details.
The government had decided to go for Clinical Trial Registry based on the recommendations of a committee under the chairmanship of V N Rajasekharan Pillai.
The committee was formed following media reports that illegal clinical trials were being conducted in the state.
It was found that the institutions which conduct clinical trials in the state were not following the conditions stipulated as per rules.
The committee also found that the patients on whom the studies were conducted were often selected through medical camps organised in remote villages, and mostly illiterate or people from low income groups were selected for these studies.
Health Secretary K Ellangovan said that the government had asked the Drugs Control Department to formulate the guidelines.
‘’The Drugs Control Department will be having a monitoring role.
“And entrusting this role to the Department does not mean that the doctors will be avoided.
The clinical trials will be done only by the doctors and it will be monitored by the Department,’’ he said.
Sources said that all the centres and hospitals which conduct clinical trials should have to get registered, satisfying the conditions for trials.
The State Board of Medical Research will be entrusted with giving periodic training to investigators of clinical trials.